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Displaying 1 - 65 of 65
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 / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of this study is to test whether BMS-986393 in combination with other anti-cancer drugs is safe and effective at treating people with multiple myeloma (MM) that has come back after previous treatment (relapsed) or is not responding to current treatment (refractory). The researchers think that the combinations of alnuctamab, mezigdomide, or…
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 / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of this study is to see how teclistamab by itself compares to study treatment combinations that are commonly used to treat multiple myeloma. These study treatment combinations are either pomalidomide, bortezomib and dexamethasone (called PVd) or carfilzomib and dexamethasone (called Kd). The patients will be randomly assigned to one of the study…
Condition: Cancer / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of this study is to see if Isatuximab can alter the immune system favorably in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. This study will have two arms. On one arm (control arm), Participants will receive standard transplant procedures and on the other arm (experimental arm),…
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: Cancer / Multiple Myeloma
Investigator: Ran Reshef, MD
Status: Closed
The purpose of this study is to determine if the investigational therapy called bb2121 is effective in treating multiple myeloma. bb2121 is a type of therapy known as chimeric antigen receptor (CAR) T-cell therapy. T cells are a kind of white blood cell which form part of your body's immune system. Your T cells will be separated from the rest of the…
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: 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: Cancer / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
This study will look at the safety of a drug (REGN5458) in patients with multiple myeloma. It will also try to find out what the best dose of REGN5458 is and look for any signs that REGN5458 can help treat your cancer. REGN5458 is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) for any condition.
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: Blood Disorders / Amyloidosis
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of the study is to determine if the drug, CAEL-101 in combination with plasma cell treatment improves overall survival for patients who are diagnosed with stage 3b of AL amyloidosis. Patients who participate in this study will receive CAEL-101 as well as plasma cell treatment or Placebo as well as plasma cell treatment to compare the effects.
Condition: Blood Disorders / Amyloidosis
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of the study is to determine if the drug, CAEL-101 in combination with plasma cell treatment improves overall survival for patients who are diagnosed with stage 3a of amyloid light chain (AL) amyloidosis. Patients who participate in this study will receive CAEL-101 as well as plasma cell treatment or Placebo as well as plasma cell treatment to…
Condition: Cancer / Multiple Myeloma
Investigator: Ran Reshef, MD
Status: Closed
The purpose of this study is to determine if the investigational therapy, bb2121, in combination with other treatments, is safe and effective in treating relapsed and/or refractory multiple myeloma.
Condition: Cancer / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
You are being asked to take part in this study because you have Multiple Myeloma. This study is being done to learn more about AMG 701 in people with Multiple Myeloma. It will see if AMG 701 is safe and tolerable and whether it causes any side effects. This study will also look at what doses of AMG 701 are safe for people to take and what the effect on…
Condition: Cancer / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
This is a research study. We invite you to participate in this research study because you have been diagnosed with Multiple Myeloma (MM). Your previous treatment(s) has/have not been successful and your cancer is progressing. The purpose of this research study is to see if selinexor (also known as KPT-330) has any effects on your cancer. Selinexor is…
Condition: Cancer / Multiple Myeloma
Investigator: Ran Reshef, MD
Status: Closed
The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR269A to treat certain types of cancers. PBCAR269A is a new investigational treatment for certain types of cancer of the blood, such as multiple myeloma. It is made from a type of blood cells known as T cells. The T cells in PBCAR269A came from people who have…
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: 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: Blood Disorders / Amyloidosis
Investigator: Suzanne Lentzsch, MD
Status: Closed
The purpose of this study is to evaluate the safety and effectiveness of an antibody drug (STI-6129) in patients with AL amyloidosis that has returned or has not responded to treatment (relapsed/refractory). The study drug (STI-6129) will be given in 3 injections through a needle, into a vein as an intravenous (IV), with 21 days between each injection.
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: 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: Blood Disorders / Amyloidosis
Investigator: Suzanne Lentzsch, MD
Status: Closed
The study is being done to see if the combination of bendamustine and dexamethasone will help people with amyloidosis that has returned after standard treatment. Bendamustine is currently approved by the Food and Drug Administration (FDA) for treatment of chronic lymphocytic leukemia (CLL) and is under clinical development in the United States for the…
Condition: Cancer / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
The purpose of this research study is to explore the drug combination, lenalidomide, bortezomib, and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma.
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: Cancer / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of this study is to find out whether treatment with daratumumab and lenalidomide will make your Multiple Myeloma better. There are 2 treatment groups in this study. You will either receive lenalidomide alone or both lenalidomide and daratumumab along with medications to take before and after the daratumumab injection.
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: Blood Disorders / Amyloidosis
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of this study is to see if daratumumab when given with three other drugs cyclophosphamide, bortezomib (VELCADE) and dexamethasone is useful for treating patients with Amyloid light chain Amyloidosis (also known as AL Amyloidosis). The study will look at what happens (both good and bad) when daratumumab is given with these three drugs compared to…
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: Cancer / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
The purpose of this study is to look at what happens (both good and bad) when daratumumab is given with two other drugs called VELCADE and dexamethasone compared to just giving those two drugs, VELCADE and dexamethasone, alone. VELCADE is also known by the name bortezomib. Giving VELCADE and dexamethasone together is standard treatment for advanced multiple…
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 / Multiple Myeloma
Investigator: Siyang Leng, MD
Status: Closed
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, pembrolizumab (MK-3475) with or without pomalidomide and low dose dexamethasone in subjects with refractory or relapsed and refractory Multiple Myeloma (rrMM) measured by the rates of response to treatment, disease progression (disease getting…
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 / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
This is a study of a study drug, Carfilzomib in combination with bendamustine and dexamethasone for subjects with newly diagnosed multiple myeloma. The purpose of this study is to find the highest tolerable dose of carfilzomib with the combination of bendamustine and dexamethasone. The response rate and the safety of this drug combination will also be…
Condition: Cancer / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of this study is to compare the effectiveness of venetoclax and dexamethasone versus pomalidomide and dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) multiple myeloma.
Condition: Blood Disorders / Amyloidosis
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to evaluate the efficacy and safety of ION-682884 given for 24 months in patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN) also known as Familial Amyloid Polyneuropathy (FAP), and determine if it can help people with mild or moderate polyneuropathy. To be in this study you must have FAP and be…
Condition: Cancer / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
This research study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in subjects with untreated multiple myeloma. This comparison will include how many subjects respond to each study treatment combination, how long…
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: Blood Disorders / Amyloidosis
Investigator: Suzanne Lentzsch, MD
Status: Closed
The purpose of this study is to evaluate whether study drug NEOD001 will improve survival in subjects with AL amyloidosis and/or increase the interval of time that they can go without requiring hospitalization for problems with their hearts. This study will also evaluate whether NEOD001 improves the function of subjects' organs that have been affected…
Condition: Cancer / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
The purpose of this study is to find out how well Daratumumab works when it is given along with two other drugs called Lenalidomide and Dexamethasone compared to the drug combination of Lenalidomide and Dexamethasone to treat multiple myeloma.
Condition: Cancer / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
Belantamab Mafodotin is a new therapy for patients with Multiple Myeloma. The drug works by combining chemotherapy and immunotherapy approach to treat Multiple Myeloma. The drug is a combination of an antibody against a target on plasma cells called BCMA and a chemotherapeutic agent called MMAF. The drug has shown activity in patients with late relapses of…
Condition: Cancer / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
This is a research study for subjects who have been diagnosed with multiple myeloma, a cancer of plasmacells (a type of immune cell that produce antibodies) in the bone marrow, that has returned (relapsed) or has not responded (refractory) to your most recent treatment regimen.The subject's disease has also progressed after prior treatment with…
Condition: Cancer / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
We are doing this study to learn if the MMprofiler test can help your doctor in making decisions about your treatment. The MMprofiler genomic test will look at a large number of normal genes. The test will predict risk of your multiple myeloma (MM) by assessing whether these genes are turned on or off in your cancer cells. The purpose of this research is to…
Condition: Blood Disorders / Amyloidosis
Investigator: Suzanne Lentzsch, MD
Status: Closed
The purpose of this study is to find out if MLN9708 plus dexamethasone improves against systemic light chain amyloidosis better than the physicians choice chemotherapy treatment. Physicians choice chemotherapy treatment is a treatment regimen that is commonly used to treat amyloidosis patients. The study will also determine if MLN9708 plus dexamethasone can…
Condition: Cancer / Multiple Myeloma
Investigator: Yvonne Saenger, MD
Status: Closed
The purpose of this study is to test two imaging techniques, one called whole body diffusion weighted magnetic resonance imaging (WB-DWI MRI), and another called F-18 3-deoxy-3-fluorothymidine PET (F-18-FLT PET). The goal is to see whether these imaging techniques would allow the study doctors to see changes in the size of a tumor earlier for patients with…
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: Blood Disorders / Amyloidosis
Investigator: Thomas Brannagan, MD
Status: Closed
HELIOS-A is a global Phase 3 randomized, open-label study designed to evaluate the safety and efficacy of ALN-TTRSC02 in adult patients with hATTR amyloidosis experiencing neurologic symptoms brought on by the disease. The study will also evaluate any changes in quality of life experienced by study participants. ALN-TTRSC02 utilizes the mechanism of RNA…
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: 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 / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
The main goals of this study are to evaluate the safety of the combination of the study drug radium-223 dichloride plus bortezomib and dexamethasone and to determine the optimal dose of radium-223 dichloride to be used in combination with bortezomib and dexamethasone. Radium-223 dichloride has been approved in some countries for treatment of patients with…
Condition: Blood Disorders / Amyloidosis
Investigator: Suzanne Lentzsch, MD
Status: Closed
This is a research study for subjects that have been previously treated for systemic light chain (AL)amyloidosis (a disease in which abnormal protein deposits can damage organs and tissues in your body) and nowrequire further treatment. The main purpose of this study is to evaluate the safety and determine the maximum tolerated dose of aninvestigational new…
Condition: Cancer / Multiple Myeloma
Investigator: Suzanne Lentzsch, MD
Status: Closed
This is research study for patients who have been newly diagnosed with Multiple Myeloma (MM). Their previous treatments have not been successful and their cancer is progressing. The purpose of this research study is to see if the study drug selinexor (KPT-330) has any effects against their cancer. This study combines the use of two drugs, selinexor (KPT-…
Condition: Cancer / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Closed
This study will look to obtain information on the best dose of the research drug, TAK 079, when administered in combination with other approved multiple myeloma treatments for patients with newly diagnosed multiple myeloma. If you participate you will receive either Arm A (TAK-079 in combination with lenalidomide and dexamethasone) or Arm B (TAK-079 in…
Condition: Blood Disorders / Amyloidosis
Investigator: Suzanne Lentzsch, MD
Status: Closed
The purpose of this study is to test for any good and bad effects of the study drug called isatuximab. Isatuximab may or may not improve your AL amyloidosis, but it could also cause side effects. Isatuximab is not approved by the Food and Drug Administration (FDA). Isatuximab has been shown to have good effects in some patients with recurring multiple…