Clinical Trials

  • REST: Sleep Study for High School Students

    Principal Investigator:

    Brooke Aggarwal, EdD, MS, FAHA
    High school students ages 14-18 and their parent(s) may be eligible to participate in a 12-week (consisting of a 6-week pre-pilot and 6-week pilot) sleep health education program.

  • REST: Sleep Study for High School Students

    Principal Investigator:

    Brooke Aggarwal, EdD, MS, FAHA
    High school students ages 14-18 and their parent(s) may be eligible to participate in a 12-week (consisting of a 6-week pre-pilot and 6-week pilot) sleep health education program.

  • Study of OPTIMIZER System in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF)

    Principal Investigator:

    Hirad Yarmohammadi, MD
    You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy, CCM therapy, called the OPTIMIZER System.

  • The ALL-RISE Study

    Principal Investigator:

    Margaret B. McEntegart, MD
    This is a prospective, randomized, multi-center, controlled post-market study. The ALL-RISE study is looking at Fractional flow reserve (FFR) which is a medical test that doctors use to check how narrow the heart arteries are and decide if a stent or other treatment is needed. It helps doctors determine if the blockage is causing significant reduction in blood flow and guides them in making better choices for how to treat patients. The goal is to see if an image-based software system called FFRangio can accurately measures blood pressure and flow through the arteries as compared to using a...

  • The BREAK II Study: Breaking up Prolonged Inactivity to Improve Cardiometabolic Health

    Principal Investigator:

    Keith Diaz, PhD
    U.S. Adults spend on average 11 to 12 hours a day in sedentary behavior. Daily sedentary behavior is strongly associated with risk of cardiovascular disease. The purpose of the BREAK II research study is to answer two questions: (1) How frequent should periods of prolonged sedentary time be interrupted? and (2) What is the appropriate duration or length of time of these breaks in sedentary time? If you are 18 years old or older and have no history of chronic diseases, and no physical disability preventing ability to walk and a non-smoker you may be eligible for this study. Participants will...

  • The CORCINCH-HF Study: Study of AccuCinch in Patients with Symptomatic Heart Failure with Reduced Ejection Frraction (HFrEF)

    Principal Investigator:

    Gabriel Tal Sayer, MD
    This is a prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Repair System in patients with heart failure and reduced ejection fraction (HFrEF).

  • The Half Moon Transcatheter Mitral Valve Repair (TMVr) Study

    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...

  • 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...

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