This is a prospective, single-center, single-blind, two-arm, 1:1 randomized clinical trial. Patients who have undergone successful elective PCI will be screened with a lipid profile and eligible patients will be enrolled. Non-eligible patients will be enrolled in a registry. Randomization will be stratified by baseline LDL-C level and current statin therapy…
Tricuspid Regurgitation is a disorder in which the Tricuspid valve, the valve in between the two right chambers that does not close properly. As a result, blood flows backward through the Tricuspid valve. The Edwards Tricuspid Transcatheter Repair System includes an artificial device, made to serve as a spacer to treat the diseased tricuspid heart valve.
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of…
We are working with researchers at Columbia University to test whether text messaging can be used effectively to help people with hypertension to control their blood pressure. If you are between the ages of 18 and 85 years and have a cell phone, you may be eligible to participate in this study. The study would involve a telephone call that would last about…
This study is being done to test the orally administered study drug, CA-4948 alone, in combination with ibrutinib, or ibrutinib alone in adult patients ages 18 and over diagnosed with relapsed or refractory (RR) Primary Central Nervous System Lymphoma (PCNSL). This study will take place at multiple centers globally. The study drug, CA-4948, is thought to…
The purpose of this study is to find out if performing Magnetic Resonance Image (MRI) scans of your brain with adaptive planning during your radiation treatment of your high-grade glioma will help determine how sensitive the images collected of the brain are at detecting the response of the tumor to the cancer treatment. In this study, four or seven MRI…
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to…
The purpose of this study is to determine whether treatment with anticoagulation medications incombination with the EkoSonicTM Endovascular device with a dose of a clot-dissolving drug(thrombolytic) can reduce the risk of death and other serious problems when compared to anticoagulation medication alone. Other measurements will be taken to observe your…
The purpose of the study is to evaluate the safety of Lutathera alone in patients with recurrent glioblastoma and the combination of Lutathera with radiotherapy with temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB) and to establish the appropriate dose of this combination. Lutathera is a radioligand therapy, which is a targeted…
This is a randomized controlled trial (RCT) that will compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. In this trial,…
You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy called the OPTIMIZER System. The OPTIMIZER INTEGRA CCM-D System, also known as a Cardiac Contractility Modulation Defibrillator, is an investigational device system that combines CCM therapy and ICD therapy into one device.…
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
The Edwards Cardioband Tricuspid Valve Reconstruction FIT valve repair system is a prospective, single arm, multi-center study to evaluate the safety and performance of the Cardioband Tricuspid System. The Edwards Cardioband Tricuspid Valve Reconstruction System is intended for patients with tricuspid regurgitation deemed to be potential candidates for…
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-…
The purpose of this study is to explore sources of stress, stress management techniques, and health behaviors associated with heart disease risk among transgender and gender diverse adults (ages 35 to 64 years). We also hope to identify preferences for an intervention to reduce heart disease risk among transgender and gender diverse adults. Participants…
The primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI…
Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine…
The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with meningioma.…
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need for treatment. This is a study that is collecting safety and…
This is a prospective, single-arm, multi-center, early feasibility study. This research study is for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart…
The goal of this present study is to determine the feasibility of recruiting lesbian, gay, bisexual, and queer (LGBQ) adults ages 40-64 years for a stress management intervention to reduce heart disease risk among LGBQ adults. Taking part in this study will last approximately 30 minutes and includes completing a brief questionnaire via video conference or…
This is a prospective, randomized, multi-center, controlled post-market study. The ALL-RISE study is looking at Fractional flow reserve (FFR) which is a medical test that doctors use to check how narrow the heart arteries are and decide if a stent or other treatment is needed. It helps doctors determine if the blockage is causing significant reduction in…
The purpose of this study is to find out if REC-2282, an investigational new drug, is an effective and safe treatment in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutation. Investigational new drug means a drug that has not been approved as a marketed…
The purpose of this study is to see how safe and effective Safusidenib erbumine, the study drug, is in treating brain glioma and to find the recommended dose of the study drug for clinical studies. Safusidenib is not Food and Drug Administration (FDA) approved.
The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure. The study will…
We are doing this study to collect sensor and heart failure (HF) event data that will be used to develop and test new diagnostic (not providing therapy) features for the insertable cardiac monitor (ICM) systems. ICMs are small devices implanted under the skin and are now widely used for the long-term monitoring and detection of abnormal heart rhythms. ICMs…
This is a prospective, multicenter, open-label, single-arm study that seeks to confirm and describe the safety and effectiveness of the GSO device as observed in the REDUCE pivotal IDE study. It is also designed to demonstrate acceptable performance of the GSO device in patients treated with percutaneous, transcatheter PFO closure plus anti-platelet medical…
The purpose of this study is to evaluate how safe the investigational drug, DSP-0390, is at different doses and to identify a recommended dose that is safe for further study. Investigational means that the study drug is currently being tested and has not been approved for use alone or in combination with any drug by the U.S. Food and Drug Administration (…
The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placebo see if it works in slowing glioblastoma multiforme (GBM) tumor regrowth. SOC refers to the usual medicine(s) or procedures used to treat your cancer. A placebo looks like the study medicine but does not contain any…
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
The use of electronic cigarettes, also known as e-cigs or vaping, has increased among former smokers and young adults who have never smoked. Relatively little is known, however, about their health effects (whether they are adverse, have no effect, or are beneficial). The purpose of this research study is to evaluate (1) the association of e-cig use with…
We are conducting a research study in adults to test whether blood pressure (BP) measured in a clinic setting without a technician present is comparable to blood pressure levels while awake outside of the clinic on an Ambulatory Blood Pressure Monitoring (ABPM) device. We will also test whether asleep blood pressure can be accurately determined using a home…
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the hearts tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.…
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
We are currently looking for men and non-pregnant women aged 40 years and above to participate in an at-home study on sleep and activity patterns in relation to blood pressure and blood glucose. Participants should not have critical/severe illness and should not be on dialysis or have a pacemaker or other implanted medical device. You must be willing to…
We are currently looking for Hispanic/Latino men and women aged 30-65 years to participate in a study to help create sleep programs for better health. Participants will attend a discussion group about sleep health and give their opinion about a sleep health program. Compensation of $40 will be provided at the end of the discussion group. You will have the…
Atrial fibrillation (AFib) is an arrhythmia (abnormal heart rhythm) that causes the heart's upper chambers (the atria) to beat very fast and irregularly. The purpose of this study is to determine if early study treatment with the medicine dronedarone is more effective than usual care alone for the prevention of unplanned cardiovascular hospitalization…
The purpose of this research study is to understand if aspirin is needed in patients heart failure implanted with the HeartMate 3. Patients with devices like the HeartMate 3 take two blood thinner medicines, specifically warfarin and aspirin. Patients implanted with devices like the HeartMate 3 experience both clotting and bleeding complications. Data…
We are doing this study to gather information on participants returning at time of Cardiovascular Implantable Electronic Device (CIED) change-out or revision who underwent a device implantation with either a CanGaroo envelope, Tyrx envelope, or no envelope. A CIED is a device implantable inside the body, able to conduct pacing of the heart and therefore…
We are seeking adults with cardiovascular disease who identify as Black/African American or LatinX, and/or their caregivers, as well as community health workers working in primarily Black/African American or LatinX neighborhoods of NYC, to participate in a brief (30-minute) interviews over the phone or Zoom to discuss attitudes and perceptions related to…
The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas, which is a kind of brain tumor. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor…
The purpose of this study is to determine the safety and long-term effects of CK-3773274 and to learn how well it is tolerated at different, increasing dose levels in participants with HCM.
This study is trying to determine if using a Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides imaging support while directing the…
The purpose of this research is to evaluate the safety and performance of an experimental system called the Aortix System. The system is being designed for use in patients hospitalized for a worsening of their heart failure symptoms and who also show signs of strain on their kidneys. The Aortix System includes a pump, which we hope may help the heart and…
The purpose of this research study is to see if the combination of medications approved for the treatment of glioblastoma, together with the study drug, selinexor (also known as XPOVIO), has any effects on your cancer. Selinexor works by trapping tumor suppressor proteins within the cell nucleus. This is expected to cause the cancer cells to die or stop…
This is a prospective, multi-center, observational, post-market study that will evaluate the safety and procedural success of performing trans-radial access for treatment of atherosclerotic lesions in the lower extremities. This research study will collect outcome data of patients undergoing percutaneous endovascular treatment of Peripheral Artery Disease (…
This is a prospective, single arm, three stage, multi-site, clinical investigation evaluating the safety and efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant hole in the atrial septal defect compared to other commercially approved devices. The study is being done to determine the safety and efficacy of…
This study is being done to evaluate the safety and usefulness of the study drug, AG-881, as compared to placebo (a medically inactive substance) in residual or recurrent non-enhancing Grade 2 glioma (a type of brain cancer) that has a mutation in the IDH1 or IDH2 metabolic enzyme (a substance produced by the body to assist in breaking down chemicals).…
The purpose of this research study is to test how safe and how well an investigational drug known as ONC201 works in treating high grade glioma (a type of brain cancer). The FDA (the U.S. Food and Drug Administration) has not approved ONC201 as a treatment for this condition.
A study to find out if the experimental drug ARRY-371797 vs. placebo has beneficial effects on ability to walk over a 6-minute period (as measured by the 6-minute walk test) in adults with genetic dilated cardiomyopathy.
This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition…
The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Safety and how well you can tolerate the drug will be determined on the basis of physical exams, laboratory tests,…
RADIANCE II is a randomized, double-blind, sham-controlled, single cohort study designed todemonstrate the effectiveness (how well it works) and safety of the Paradise Renal Denervation System in hypertensive subjects (subjects with high blood pressure).
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The Millipede Annuloplasty Ring System is a novel transcatheter, fully adjustable, complete annuloplasty repair device for the treatment…
This prospective, multicenter, open-label, single arm, first-in human study will enroll up to 75 subjects aimed at examining the performance of the LAAC device for LAA closure.
A randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HSY244 in participants with AF. Participants will be randomized and assigned to one of the following 2 treatment arms in a ratio of 1:1. Arm 1: HSY244 intravenous infusion; Arm 2: Placebo intravenous infusion…
In this study, patients with heart failure, will undergo a cardiac catheterization procedure which either includes injections of stem cells from healthy young adults into the heart or a sham (mock) procedure that does not include injection of the stem cells. This is a study of an experimental product called rexlemestrocel-L.
This trial is a non-randomized, prospective, multi-center early feasibility study to evaluate the safety and performance of the AccuCinch system in patients with Heart Failure and Reduced Ejection Fraction HFrEF
The purpose of this study is to evaluate two different types of devices that measure pressure across the coronary arteries, which are vessels that supply blood to the heart. This is being done in order to see if they are equally accurate or if one performs better than the other. These devices are called Fractional Flow Reserve (FFR) . The devices that will…
Two different studies have been developed to treat people with anaplastic glioma brain tumors. Onetreatment research study requires a tumor that has the 1p/19q co-deletion tumor marker; the other does not. This treatment research study requires that the subject has a certain kind of tumor, one that is missing part of both chromosomes 1 and 19. These missing…
The purpose of this study is to test whether the new drug, ABT-414, given either alone or with a drug called temozolomide, which is commonly used to treat brain tumors like yours, gives a better outcome than the standard therapy and is safe. The standard therapy can be one of two different regimens, either a drug called lomustine or temozolomide.
The Saranas Early Bird Bleed The Saranas study uses a device is called the Early Bird Bleed Monitoring System (EBBMS) and it is intended to provide physicians with an early indication of a potential internal bleeding complication due to vessel injury that may occur during the procedure before any symptoms present.
The purpose of this study is to see if a new medication called ticagrelor given twice daily ismore effective than aspirin alone in preventing the occurrence of heart attack, stroke and/ordeath due to cardiovascular events in patients who have type 2 diabetes. Ticagrelor is anantiplatelet therapy (stop platelets from clumping together) and is approved for…
The REDUCE LAP-HF I study is being conducted to evaluate the safety and performance of the InterAtrial Shunt Device (IASD) for patients with elevated left atrial pressure who remain symptomatic despite appropriate medical management. Placed by an interventional cardiologist during a standards catheter-based procedure, the IASD system creates a very small…
This is a multicenter, prospective randomized study to determine the safety and efficacy of the Watchman device in patients with irregular heart beat undergoing a less invasive procedure than open heart surgery called Transcatheter Aortic Valve Replacement (TAVR). In this procedure, an x-ray is used to visualize and guide the Watchman device via a catheter…
A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are…
The purpose of this study is to: See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue. See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer-related fatigue
This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from…
The purpose of this study is to collect information about the safety and performance of the investigational leads ACUITY X4 and RELIANCE 4-FRONT. Patients who have been determined to require a Cardiac Resynchronization Therapy Defibrillator (CRT-D) to treat their heart condition will be eligible to be implanted with one or more investigational leads. The…
This research study is for patients with severe aortic stenosis. Patients may be considered for this study if they have a diseased aortic heart valve and who are at low operative risk for standard (traditional) open-heart surgery for aortic valve replacement (TAVR).
The purpose of this study is to find out whether an experimental drug, bevacizumab with temozolomide is safe when given to elderly patients with brain tumors and investigate the side effects of the drug combination and how often they occur. This study will also explore whether bevacizumab and temozolomide can be effective in shrinking tumors when given to…
In this research study, we are looking for Information on how well nivolumab with or without ipilimumab works in combination with TTFields in adult patients with glioblastoma. You will receive the Nivolumab and/or Ipilimumab study treatment until you decide to stop study treatment or your study doctor decides to remove you from the study. This means that…
This clinical trial is for patients diagnosed with carotid artery stenosis that are at high risk of a stroke. Carotid artery stenosis develops as a result of plaque buildup in the carotid artery. Over time plaque buildup creates a narrowing of the carotid artery, restricting the flow of blood. Thus, increasing the risk of stroke. In this research study the…
The purpose of this study is to see if study drug GS-6615 improves the symptoms of Hypertrophic Cardiomyopathy (HCM) and helps the heart work better. HCM is a disease that affects the muscle of the heart. HCM is a condition in which the heart muscle becomes abnormally thick for no clear reason. This can make it harder for blood to enter and leave the heart…
The purpose of this study is to determine the safety of directly injecting a tumor chemotherapy drug called Topotecan and a contrast agent called Gadolinium into malignant brain tumors.
This is a research study to test the effects of VB-111 combined with Bevacizumab versus Bevacizumab alone on glioblastoma . This study will enroll 252 subjects age 18 years and older who have recurrent glioblastoma. All subjects will be randomly assigned in a 1:1 ratio to receive either VB-111 combined with Bevacizumab or Bevacizumab alone. Survival, tumor…
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
The purpose of this clinical investigation is to collect human clinical data in order to demonstrate thatthe EDWARDS INTUITY Valve System, EDWARDS INTUITY Aortic Valve, Model 8300ACA/ACD issafe and works properly as an aortic valve replacement and that the EDWARDS INTUITY ValveSystem, EDWARDS INTUITY Delivery System, Model 8300DCA/DCD is safe and works…
This study is looking to compare the regular dose flu shot to a high dose flu shot, in patients who have had a heart attack in the past year, or have been in the hospital for heart failure in the past 2 years. All subjects enrolled will receive a flu shot and will be closely monitored by the study team.
This observational study is designed to collect and evaluate information describing patients undergoingTAVR using two different clinical pathways. Information describing both groups will be analyzed tocompare safety and clinical outcomes. A quality of life and cost analysis will be performed to comparepatients in the Vancouver 3M Clinical Pathway with those…
The purpose of this study is to test how well the study drug works in recurrent or isocitratedehydrogenase (IDH) mutant high grade gliomas. The study drug is called Nivolumab. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow your own body's immune system to work against tumor cells. Nivolumab is not…
The purpose of this research study is to learn about the effects of the study drug, PF-06840003,and to find the best dose for treating research subjects/participants with malignant glioblastoma or anaplastic glioma. PF-068400003 is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country. PF-…
The purpose of this study is to compare the safety and effectiveness of an approved medical device (OCT) which will be used to help select and guide the stenting procedure by collecting images and flow measurements inside the blocked arteries in comparison to both standard angiography and another medical device (IVUS). Coronary Artery Disease is the…
The purpose of this outpatient study is to examine if oral Spironolactone (100mg/day) in addition to loop diuretics (water pills) can improve signs and symptoms of fluid retention in patients with heart failure and prevent hospitalization.
This study has been designed to treat patients with a pulmonary conduit or valve that has a large amount of regurgitation or is too narrow and needs to be replaced.
This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.
This is a two-part research study of an investigational drug called ABBV-321 in subjects with glioblastoma (brain tumor). This study will be conducted in two-parts: 1) Dose Escalation Phase: The purpose of the first part, called a Dose Escalation Phase, is where we will increase the dose of ABBV-321 until we find the highest dose before unmanageable side…
This is a prospective, multi-center, single-arm study aimed at finding out if the clinical performance of a device called the Orsiro stent, in a real-world setting is similar to the clinical performance observed for the device in the BIOFLOW-V IDE pivotal trial. After receiving the Orsiro stent, you will be followed through 5 years of follow-up, with…
The purpose of this study is to evaluate the safety and performance of the CytoSorb device to reduce plasma free hemoglobin when used intra-operatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery.
The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation plus memantine to using the usual whole-brain radiation plus memantine. The hippocampus is a brain structure that is important for memory. The addition of the hippocampal avoidance technique to the usual whole-brain radiation plus…
This is a Phase 2b/3 study to compare the effectiveness of the study drug ABT-414 against a placebo. Patients will be randomized to either receive the standard-of-care therapy which consists of radiation therapy/TMZ plus adjuvant TMZ which will be followed by eiter the study drug ABT-414 or a placebo monotherapy.
The purpose of this study is to compare the effect of the investigational drug, Mavacamten, to a placebo (an inactive drug). This is being done to evaluate whether Mavacamten is safe in obstructive Hypertrophic Cardiomyopathy (HCM) patients and helps to improve symptoms or ability to exercise. Mavacamten is an investigational drug. This means that it has…
The primary objective of the TactiFlex PAF IDE clinical trial is to demonstrate that ablation with the TactiFlex Ablation Catheter, Sensor-Enabled (TactiFlex SE), in conjunction with a compatible RF generator and three-dimensional mapping system, is safe and effective for the treatment of drug refractory, symptomatic paroxysmal atrial fibrillation (PAF)…
The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that issimpler than the open-heart procedure being used today and may be safer for patients who are at ahigher risk from conventional open-heart surgery. The device being studied would be implanted without the need for an open-heart procedure and without…
This trial is looking to enroll patients with heart failure in order to study the effect and safety of the study drug, vericiguat, when compared to a placebo. Patients will remain on their regular standard of care treatment and will receive either a placebo or Vericiguat. All patients will be monitored closely by the study team.
The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).
The purpose of this study is to find out whether an experimental device, called HeartMate PHP, can safely help maintain blood flow during angioplasty, and to compare it to an FDA approved device called Impella. This study will also evaluate the safety and efficacy of the HeartMate Percutaneous Heart Pump (HeartMate PHP) when used in patients who are…
The main purpose of this study is to improve treatment of ocular side effects that result from depatuxizumab mafodotin (Depatux-M) use in patients with glioblastoma (GBM). Most people treated with Depatux-M will experience eye side effects. When these side effects are not tolerated, Depatux-M is usually interrupted until symptoms improve and then restarted…
The purpose of this study is to assess the safety and effectiveness of a pacing device, Micra Transcatheter for patients who have been recommended to get a pacemaker because their heart beats irregularly or is too slow at certain times. A pacemaker senses your hearts activity and stimulates your heart if needed. In this study you will get a Medtronic Micra…
This study will help evaluate the progression of heart disease in people with heart failure. This will be done using 2 MRI studies, as well as a few blood tests. Depending which group you fall into you will come in for either 3 or 4 visits and 1 phone call at the 1 year mark.
The purpose of this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on…
This study is for patients with Coronary Artery Disease (CAD) and require a stent placement. The purpose of this clinical research study is to assess the safety and effectiveness of the Orsiro stent or a non-investigational Xience stent. The Orsiro stent is investigational, which means it is not yet approved by the FDA and can only be used in research…
The purpose of this study is to see if the newly discovered vaccine drug, DSP-7888, will help your immune system to fight against cancer cells that have a protein called WT1. The study will also compare the effectiveness of treatment with DSP-7888 in combination with Bevacizumab versus Bevacizumab alone in patients with glioblastoma (GBM). Bevacizumab has…
This is a research study to test the effectiveness of ICT-107, an experimental drug, with the standard of care (SOC) for treatment of glioblastoma compared to enriched blood cells (PBMC) with the SOC. The study will enroll 400 subjects age 18 years and older with newly diagnosed glioblastoma. Following an initial SOC radiation treatment, patients will be…
The purpose of this study is to find out more about how physical activity monitors can help assess patients with pulmonary hypertension. We hope to find a relationship between the data on physical activity monitors and the tests that routinely done in patients with pulmonary hypertension.
The purpose of this trial is to determine if people with impaired heart function, that may have been induced with chemotherapeutic drugs and/or radiation, will have improved heart function with a cardiac device that can pace the heart more efficiently using cardiac resynchronization therapy.
A drug study looking at the effects of 10 mg Dapagliflozin vs. Placebo in patients with Heart Failure and Preserved Ejection Fraction (HFpEF) with either diabetes or pre-diabetes.
The LOTUS Edge Valve System is intended to improve aortic valve function in symptomatic subjects with severe aortic stenosis who are at intermediate risk for standard surgical aortic valve replacement (SAVR), including those who have a bicuspid native valve. The study will include subjects presenting with symptomatic severe aortic stenosis who are…
This study is for patients who suffer from a leakage of blood within on of the valves of the heart. The leakage of blood is also called regurgitation. The valve that is leaking is called the tricuspid valve and it is located within the right side of the heart. This condition is referred to as functional tricuspid regurgitation (FTR). The treatment of FTR…
The purpose of this clinical study is to evaluate safety of the study treatment, its effects on the immune system and on GBM. The study treatment includes several experimental therapies: INO-5401 + INO-9012 delivered by an electroporation device called CELLECTRA 2000 used for delivery of INO-5401 + INO-9012 into your muscle. You will also receive another…
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the bodys immune system to work against tumor cells. The effectiveness of BMS-936558…
The purpose of this study is to test whether a device called an implantable cardiac defibrillator (ICD)can increase the likelihood of survival in patients at risk of heart rhythm irregularities as determinedby the analysis of a 24 hour monitor that is performed within 2 to 15 months after a heart attack. AnICD is a device that is implanted under the skin…
Many patients want to know which blood pressure medication is the best for them. In this study, we will test the feasibility of a new approach to determining the best blood pressure (BP) medication for individual patients by performing an N-of-1 trial in which patients will have the opportunity to test a series of 3 blood pressure medications at escalating…
The purpose of this study is to deterimine if the Drug-Coated Chocolate Touch Balloon Catheters is safe and effective compared to a drug-coated balloon that is already approved in patients with a blockage in the blood vessels of their leg.
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
The purpose of this research study is to test whether the advanced perfusion MRI done prior to starting Bevacizumab and a few weeks after starting Bevacizumab can determine your response to the treatment better than the standard MRI performed at typical time points. The researchers want to see if this type of advanced MRI is better or the same as what is…
The purpose of this study is to better understand how common CTEPH is, how the disease affects the body, and how different treatments work. This is in hope to learn how to better care for patients with this disease. Participants will be asked to complete questionnaires about their quality of life and symptoms and medical records will be looked at.
The purpose of this research study is to see if Selinexor (KPT-330) has any effects against glioblastoma, a type of brain cancer. The study will be conducted at 3-5 sites in the United States and Europe and plan to enroll 30 patients with brain cancer. Patients will be screened prior to study participation. If their brain tumor is evaluated to require…
The purpose of this study is to find out what effects, good or bad, the experimental device, NovoTTF-100A has on patients with meningioma. This study is being done because currently there are no proveneffective medical treatments for a progressive meningioma that has failed surgery and/or radiation. The NovoTTF-100A System is a portable medical device. It…
The purpose of the study is to characterize von Willebrand Factor (VWF) profiles in patients receiving HeartMate 3 (HM3) and compare them to HeartMate II (HMII) Left Ventricular Assist Device (LVAD).
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
The purpose of this study is to gather more information about how effective the St. Jude Medical (SJM) TMMasters Series 15mm Rotatable Mechanical Heart Valve (15mm valve) is at treating a child's condition, as well as collecting information about the safety of the valve. The childs surgeon will have determined that child will likely require the 15mm…
The goal of this study is to assess the safety and function of this new device to insert an artificial mitral valve. This study is for patients who are a high risk candidate for standard openheart surgery to treat their mitral regurgitation. The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery…
The purpose of this study is to look at the effects of an investigational anti-cancer drug (BGB-290) in combination with radiation therapy and/or temozolomide in patients with newly diagnosed or recurring glioblastoma. BGB-290 is expected to work by preventing cancer cells from repairing their damaged genes, causing the progression of cancer to slow down.
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells.
The purpose of this study is to evaluate the NuPulseCV intravascular ventricular assist system (iVAS), a device similar to an Intra-aortic Balloon Pump (IABP) that helps circulate blood from the heart throughout the rest of the body. This study aims to: (1) See if the iVAS improves your blood circulation (2) Better understand how the iVAS device could…
This study is to collect information about the symptoms and treatments of patient who have severely clogged arteries and to learn about their outcomes at one year. If you choose to be part of this research, we will ask you to be involved in five interviews with study staff. Each interview will take about 30 minutes of your time and we will contact you…
The purpose of this research study, is to learn whether an experimental device (called Evolut R) can help clear hardened blockage in coronary arteries (blood vessels that feed the heart muscle) in patients with a disease is called aortic stenosis.Subjects that choose to participate and are eligible will have their interventional cardiologist use this device…
The study has been designed to demonstrate the efficacy and safety of the Paradise Renal Denervation System when treating patients with high blood pressure known as hypertension. When blood pressure is persistently elevated and pushes against the walls of the artery over a long period of time it is known to cause Hypertension. The Paradise Renal Denervation…
This study is for patients who suffer from a condition where one of the blood vessels that deliver blood to your leg has a significant narrowing. This is called peripheral artery disease (PAD). The narrowing may be suitable for a treatment technique called balloon angioplasty. One of the therapies that has been used to treat PAD is balloon angioplasty. It…
This study is to test if a combination drug/device therapy using TEMSIROLIMUS (Temsirolimus Injection), with or without the generic steroid DEXAMETHASONE (Dexamethasone Sodium Phosphate Injection), can be delivered safely into the tissue around the blood vessel wall at the time of an angioplasty ( which is a a procedure to open blocked arteries and restore…
The purpose of this study is to investigate a novel treatment regimen for patients with recurrent Glioblastomas (GBM). In this phase 2 trial, the potentially synergistic action of PARP inhibition and anti-angiogenesis on DNA repair and biomarkers of angiogenesis and DNA repair will be evaluated.
This research study will evaluate the effectiveness of CEP-417 (Mesenchymal Precursor Cells (MPCs)) when administered through an injection catheter to your heart muscle improving your symptoms, helping your heart function better, improving your quality of life, and in reducing the number of times you may need to be hospitalized due to your heart failure.…
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness ofan investigational drug to learn whether the study drug works in treating a specific disease.Investigational means that the drug is being studied. In this research study, we are looking to compare the effects, good and bad, of the standard of care…
The purpose of this study is to find out whether study drug bortezomib with radiation therapy and Temozolomide is safe when given to patients with brain tumors. This study will also evaluate the side effects and see whether the combination of bortezomib with radiation and Temozolomide can be effective in shrinking tumors. Bortezomib is the investigational…
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured…
The purpose of this study is to survey patients who have undergone a percutaneous coronary intervention (PCI) at Columbia University Medical Center in which the physician used a stent called the Promus Premier stent. Patients will be asked to do a brief 15-30 minute survey regarding their health since the PCI and stent implantation.
Study for subjects with moderate-to-severe or severe functional mitral regurgitation (MR) and you have been determined to have symptoms due to heart failure despite being treated with currently available therapies, and are not an appropriate candidate for mitral valve surgery.
This study is for patients that have developed acute right ventricular failure or decompensation following LVAD implantation, post myocardial infarction, post heart transplant or post open heart surgery. The primary purpose for this study is to assess safety, feasibility and possible effectiveness of the use of the Impella RP System device in patients with…
New data from the study of ABT-414 and ABBV-221 in patients with recurrent glioblastoma multiforme (GBM) have shown several examples where it seems evidence of disease progression (cancer that continues to grow and spread) was seen in MRI images, but examination of surgically removed tissue under the microscope did not agree with the MRI.
This is a research study to test the effectiveness of Toca 511/Toca FC, an experimental drug, for treatment of recurring brain tumors compared to current standard of care. The study will enroll 370 subjects age 18-85 years who choose to undergo removal of the tumor a second time. At the time of surgery patients will be randomly assigned in a 1:1 ratio to…
The ASD study has been designed to treat patients with an atrial septal defect with the use of the cardioform ASD occluder delivery system. The study will evaluate how safe the cardioform device is and how effective it is when treating patients with an atrial septal defect.
The purpose of this study is to compare the effectiveness and safety of a study drug called apixaban on patients with non-valvular atrial fibrillation during and after treatment to put them back into a normal heart rhythm (also known as cardioversion) .
The purpose of this research is to find out whether it is safe to shorten the length of time that people at high risk for bleeding take blood thinners after being treated with a coronary stent.
The purpose of the research study is to see if selinexor has any effects against your cancer and toevaluate the side-effects of selinexor or selinexor in combination with temozolomide (TMZ ). One specific way cancer cells continue to grow is by getting rid of certain proteins called tumor suppressor proteins that would normally cause cancer cells to die.…
The purpose of this project is to collect more data about the safety and effectiveness of renal denervation (disabling of kidney nerves) for the treatment of uncontrolled hypertension. For therenal denervation procedure, the Vessix Renal Denervation System is used. The system consists of a catheter (a thin tube) and a radio frequency (RF) generator (power…
The reason for this study is to find out if the experimental study drug, tesevatinib, is effective as a possible treatment for recurrent glioblastoma. Certain genetic information about your tumor will also be collected, by drawing blood, to help better understand why tesevatinib did or did not work in treating your recurrent glioblastoma. Although…
The purpose of this study is to find out if SL-701 is safe and tolerable for patients with recurrent glioblastoma multiforme (GBM). The study will also look at what effect SL-701 has on patient's brain tumor. SL-701 is a type of anti-cancer vaccine made up of parts 3 different short proteins called "peptides" which are frequently found on…
The purpose of this study is to evaluate the Biosensors BioFreedom Biolimus A9 Drug Coated Coronary Stent on people with coronary artery disease (blockages in the heart arteries) to determine if it is safe and effective.