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:
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:
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:
Susheel Kumar Kodali, MD
The early feasibility study (EFS) of the Cardioband Tricuspid 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 transcatheter tricuspid valve reconstruction with the Edwards Cardioband Tricuspid Valve Reconstruction System by the local Heart Team.
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Principal Investigator:
Susheel Kumar Kodali, MD
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
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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:
Susheel Kumar Kodali, MD
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, each subject will be followed until their 10-year visit. Clinical Investigation visits will occur at Screening (for determination of eligibility), Baseline (after confirmation of eligibility), Index Procedure, Discharge, 30 days, 6 months, 1...
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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:
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:
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 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...
