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Displaying 1 - 56 of 56
Condition: Valve Disease / Aortic Valve Disease
Investigator: Torsten Vahl, MD
Status: Currently Recruiting
The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will…
Condition: Heart Disease / Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
This is designed for patients with severe, symptomatic mitral regurgitation who are not candidates for conventional mitral repair.
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System's implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as…
TTVR Early Feasibility Study in Patients with Symptomatic Severe Tricuspid Regurgitation - Medtronic
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
This is a research study 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 has to pump more blood with each beat to push the same amount of blood…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Isaac George, MD
Status: Currently Recruiting
This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is a progressive loss of function of the mitral valve due to…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
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…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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,…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The main purpose of the study is to determine whether the study drug, ONC-392, together with a standard of care drug PLUVICTO (Lutetium Lu 177 Vipivotide Tetraxetan), are safe and well tolerated, and whether two drugs are effective in treating prostate cancer, in comparison with the standard of care PLUVICTO alone. ONC-392 has not yet been approved by the…
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
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-…
Condition: Cancer / Prostate Cancer
Investigator: Karie D. Runcie, MD
Status: Closed
The purpose of this study is to help researchers understand more about the possible effectiveness and safety of apalutamide when given to patients with or without intermittent Androgen Deprivation Therapy (ADT) to treat metastatic Castration-Sensitive Prostate Cancer (mCSPC). Apalutamide is a type of drug that blocks the action of testosterone. By blocking…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to determine whether HB-302/HB-301 therapy is safe and well tolerated. This will be the first time HB-302/HB-301 will be tested in humans. HB-302/HB-301 has not yet been approved by the Food and Drug Administration (FDA).
Condition: Critical Illness
Investigator: Nadia Liyanage-Don, MD, MS
Status: Closed
Have you ever received treatment in an ICU, do you have a smartphone (iPhone or Android), and are you at least 18 years old? If you answered yes to the above, you may be eligible for the Messy Memories Study. All study activities are completed from the comfort of home, and participants are asked to: 1. use a smartphone to revisit memories of the ICU, and 2…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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.…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
This study aims to investigate ADXS-504 as a possible treatment for biochemically recurrent prostate cancer. ADXS-504 is a type of cancer treatment that is designed to stimulate your immune system to attack prostate cancer cells. ADXS-504 is made of bacteria that have been weakened to remove their ability to cause an infection. The bacteria have also been…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to find out whether delivering SBRT to the prostate, combined with the study drug atezolizumab, is a safe and effective treatment when given in combination with abiraterone, prednisone, and Lupron (the standard treatment for this disease). In addition, the researchers want to find out whether the study treatment works better…
Condition: Cancer / Prostate Cancer
Investigator: Karie D. Runcie, MD
Status: Closed
The purpose of this study is to assess the effectiveness and safety of combining an investigational drug called BMS-986218 (also known as Anti-CTLA4-NF monoclonal antibody), or BMS-986218 plus nivolumab, with standard of care docetaxel (chemotherapy), in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after a second-…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to determine if the addition of immunotherapy to the current standard of care for metastatic prostate cancer, chemotherapy, and hormonal therapy, is safe and improves your response to therapy. People who usually have metastatic prostate cancer to their bones and organs are usually treated with combination of chemotherapy (…
Condition: Cancer / Prostate Cancer
Investigator: Karie D. Runcie, MD
Status: Closed
The purpose of this study is to see whether immunotherapy with BMS-986218 added to degarelix (which suppresses your testosterone) given prior to surgery can decrease the chance that your cancer will come back compared to degarelix alone. People who usually have this type of prostate cancer usually do not receive any additional therapy prior to surgery.
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
In Phase 1b, the purpose is to learn how well patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) tolerate the treatment when PLX2853 is added to ongoing treatment with abiraterone acetate and prednisone. We are looking for the highest dose of PLX2853 that can be given safely to patients with your type of disease who are already on…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to test the effectiveness and safety of an experimental drug known as HPN424 (also known as study drug) in patients with advanced prostate cancer. This drug has been tested in animals but not yet in people. This study tests different doses of HPN424. We want to find out how good the drug is at treating prostate cancer. We also…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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.
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is assessing the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
This study is for patients with prostate cancer and that require treatment because their disease is now growing. The purpose of this study is to see whether immunotherapy with nivolumab added to degarelix or nivolumab and BMS-986253 added to degarelix is safe and can decrease the chance that the cancer will come back. Degarelix is a standard of care drug…
Condition: Heart Disease / Valve Disease
Investigator: Martin Leon, MD
Status: Closed
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…
Condition: Heart Disease / Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
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…
Condition: Heart Disease / Valve Disease
Investigator: Robert Sommer, MD
Status: Closed
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.
Condition: Cancer / Prostate Cancer
Investigator: Joel DeCastro, MD, MPH
Status: Closed
This research study will look at whether computer tools (also called decision aids) help prostate cancer patients better understand their treatment options and help patients talk about their treatment preferences with their doctors
Condition: Cancer / Prostate Cancer
Investigator: Edward Gelmann, MD
Status: Closed
The purpose of this study is to compare the clinical benefit (i.e., does it help to improve or slow down the cancer) of adding study drug JNJ-56021927 to combined treatment of abiraterone acetate plus prednisone to treat patients with metastatic Castration-resistant Prostate Cancer (mCRPC). This study will also evaluate the possible side effects of study…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called nivolumab when combined with rucaparib, docetaxel or enzalutamide in participants with late stage prostate cancer that was unable to be surgically removed. These three combinations: nivolumab plus rucaparib, nivolumab…
Condition: Heart Disease / Valve Disease
Investigator: Martin Leon, MD
Status: Closed
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…
Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
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…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Cancer / Prostate Cancer
Investigator: Sven Wenske, MD
Status: Closed
This study is being conducted to evaluate the performance of the ConfirmMDx and SelectMDx tests for Prostate Cancer to identify patients with increased risk for clinically significant disease, to ultimately lower the rate of repeat biopsies. Approximately 1000 people are expected to take part in this study.
Condition: Heart Disease / Valve Disease
Investigator: Emile Bacha, MD
Status: Closed
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…
Condition: Cancer / Prostate Cancer
Investigator: Charles Drake, MD
Status: Closed
The purpose of this clinical trial to find out if the investigational medication pembrolizumab in combination with enzalutamide + Androgen Deprivation Therapy (ADT) is safe and works to slow down or stop the growth of metastatic prostate cancer compared to enzalutamide + ADT alone. Pembrolizumab is a type of immunotherapy, which may help the bodys immune…
Condition: Cancer / Prostate Cancer
Investigator: Sven Wenske, MD
Status: Closed
The goal of this study is to evaluate how the results of a novel laboratory developed and validated urine test which predicts the likelihood of high grade prostate cancer will impact the decision on whether you will have a prostate biopsy to rule out prostate cancer. Approximately 1,000 subjects will be enrolled in this study. The study is expected to last…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
The purpose of this study is to see if 18FDCFPyL (PyL) PET/CT scans are able to find prostate cancer tumors. PyL is a radioactive drug (tracer) that targets prostate specific membrane antigen (PSMA). Because PSMA is a protein found mostly on the surface of prostate cancer cells, we are testing to see if PyL will be able to correctly identify prostate cancer…
Condition: Heart Disease / Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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…
Condition: Cancer / Prostate Cancer
Investigator: Emerson Lim, MD
Status: Closed
The purpose of this study is to find a more effective treatment as well as to gain a better understanding of prostate cancer. This study includes investigational study drugs which are specific for your prostate cancer (module). Treatment in each module will include an investigational medication called AZD4635 as well as another module-specific study drug(s…
Condition: Cancer / Prostate Cancer
Investigator: Emerson Lim, MD
Status: Closed
The purpose of this study is to find out if ODM-201 is effective at keeping hormone-sensitive prostatecancer under control when given in addition to standard treatment which includes androgen deprivation therapy (ADT) and docetaxel chemotherapy for six cycles. A total of approximately 1,300 men will take part in this study at a number of different locations…
Condition: Cancer / Prostate Cancer
Investigator: Charles Drake, MD
Status: Closed
We are doing this study to test a drug called MGD009. MGD009 is like an antibody, which is a protein in your blood that helps get rid of germs in your body. MGD009 is made to attach to cancer cells and to T-cells, which are a part of your immune system. Certain T cells have the ability to kill other cells, including cancer cells. By attaching to cancer…
Condition: Heart Disease / Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
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…
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
You are being asked to participate in this research study because you have been diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment. The purpose of this study is to see if changes in 18FDCFPyL (PyL) PET/CT scans before starting your new treatment and after 6 weeks on treatment is associated with…
Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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
Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Closed
This research study is investigating a new treatment for cancer that uses your immune system (a type of white blood cell called T cells or T lymphocytes) to try to attack your cancerous cells. T cells fight infections, and may attack cancer cells, in some cases. Currently, your T cells may not able to attack your cancerous cells. The use of these modified T…
Condition: Heart Disease / Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
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).
Condition: Cancer / Prostate Cancer
Investigator: Emerson Lim, MD
Status: Closed
You are being asked to join this study because you have either been diagnosed with prostate cancer and will be having surgery to remove your prostate or you will be having a prostate biopsy to look for prostate cancer. This study is looking to see if a new imaging device, diffuse optical tomography (DOT), can detect prostate cancer. We will also see if DOT…
Condition: Cancer / Prostate Cancer
Investigator: Richard Carvajal, MD
Status: Closed
This study will enroll participants with prostate cancer that were treated by removing the prostate or by giving radiation (or both), but whose blood prostate specific antigen (PSA) level is going up. PSA is produced by the prostate and other tissues, and when it goes up, it means that the prostate cancer is coming back. In this study, participants will…