Enrolling Clinical Trials
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Principal Investigator:
Robert J. Sommer, MD
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 management compared to performance goals derived from REDUCE study results.
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Principal Investigator:
Tamim M. Nazif, MD
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-expanding implant that restores competency in a sclerotic aortic valve. To implant the device, a surgical incision is made in the femoral vein (incision in the upper leg between the knee and the hip). A catheter is advanced into the heart access...
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Principal Investigator:
Susheel Kumar Kodali, MD
This is designed for patients with severe, symptomatic mitral regurgitation who are not candidates for conventional mitral repair.
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Principal Investigator:
Susheel Kumar Kodali, MD
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 Systems 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 standard of care) compared to OMT alone in participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (tricuspid valve repair that is performed via open-heart surgery) and may be...
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Principal Investigator:
Sahil A. Parikh, MD
The objective of this study is to learn more about how safe and effective the Bare Temporary Spur Stent System is when used in patients who have blocked arteries in their lower limbs. The selection of subjects will be those with Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in the lower leg (calf) may have become blocked. To improve blood flow to the lower leg, the study doctor will open up this blockage using the Bare Temporary Spur Stent System.
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Principal Investigator:
Sahil A. Parikh, MD
This study is to collect information about the symptoms and treatments of patient who have severely clogged arteries and treated with commercially available Boston Scientific Corporation drug-eluting devices marketed for treatment of lesions located in the peripheral vasculature. If you choose to be part of this research, we will ask you to be involved in office visits at 6, 12, and 24 months as well as follow-up at 36, 48, and 24 months will be completed in office or remotely. Your involvement in the research will last for 5 years. There are no or minimal risks from participating in this...
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Principal Investigator:
Robert J. Sommer, MD
This study will evaluate Patent Foramen Ovale (PFO) closure for migraine headache relief using a device called the GORE CARDIOFORM Septal Occluder. A patent foramen ovale (PFO) is a hole in the heart that didn't close the way it should after birth. During fetal development, a small flap-like opening the foramen ovale is normally present in the wall between the right and left upper chambers of the heart (atria). Most patients with a PFO do not have any symptoms. However, the condition may play a role in migraine headaches and it increases the risk of stroke, transient ischemic attack (stroke...
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Principal Investigator:
Hirad Yarmohammadi, MD
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 capable of correcting most life-threatening abnormal heart rhythms. People who have had surgery to implant a medical device that helps their heart, may have had their surgery done in slightly different ways. In this study, the investigators...
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Principal Investigator:
Susheel Kumar Kodali, MD
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 effectiveness data in a high or extreme surgical risk patient population with symptomatic, severe native AS and who meet eligibility criteria for implantation of the PorticoNG valve. The Portico NG Valve (along with the delivery and loading...
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Principal Investigator:
Nir Y. Uriel, MD
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 suggest the HeartMate 3 may not require as much anticoagulation (blood thinners) as are normally used. This study will test if patients need aspirin together with warfarin or just warfarin alone.
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Principal Investigator:
Susheel Kumar Kodali, MD
Assessing the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation associated with heart failure.
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Principal Investigator:
Susheel Kumar Kodali, MD
This Early Feasibility Study (EFS) is looking at the investigative device called the Half Moon TMVrSystem to see if it is safe and effective in treating patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery. The system is designed so that a catheter can gain access to the heart by way of a large artery in the leg or by a small surgical passage through the walls between the right and left chamber of the heart. The implant then anchors on the leaflets of the valve in a certain manner. The Transcatheter Mitral Valve Replacement system...
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Principal Investigator:
Susheel Kumar Kodali, MD
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 will be treated with the Leaflex Performer in up to 7 clinical sites. All enrolled patients will be followed up at 30 days and at 3, 6, 9, and 12 months post-procedure.
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Principal Investigator:
Susheel Kumar Kodali, MD
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 Group: Doctor will use the SAPIEN 3 or SAPIEN 3 Ultra Transcatheter Heart Valve system to replace your valve. or (2) Clinical Surveillance Group: If assigned to this group, subject will not have their heart valve replaced. However, the...
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Principal Investigator:
Michael B Collins, MD
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 what is currently used for patients with reduced left-sided heart function. Participants will be assigned by the flip of a coin to receive the Impella device, or assigned to receive standard of care treatment. Participants will have a...
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Principal Investigator:
Susheel Kumar Kodali, MD
This study is for patients who require an aortic valve replacement due to severe aortic stenosis.
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Principal Investigator:
Susheel Kumar Kodali, MD
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 has to pump more blood with each beat to push the same amount of blood forward. The goal of this study is to evaluate the safety and performance of the Evoque system with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of...
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Principal Investigator:
Susheel Kumar Kodali, MD
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 forward. The goal of this study is to gain early clinical insight into how the Intrepid transcatheter tricuspid valve replacement (TTVR) system device performs. There is a need for alternative and less invasive treatment options to treat this...
