Clinical Trials

  • The Leaflex Early Feasibility Study Protocol in Patients with Symptomatic Severe Aortic Stenosis

    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.

  • The PROTECT IV Trial

    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...

  • TRISCEND ll PIVOTAL Study of the Edwards EVOQUE Tricuspid Valve Replacement System

    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...

  • TTVR Early Feasibility Study in Patients with Symptomatic Severe Tricuspid Regurgitation - Medtronic

    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...

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