Clinical Trials

  • Study of Cuffless Upper Arm Ambulatory Blood Pressure Monitor and Mobile App - Healthy Volunteers

    Principal Investigator:

    Daichi Shimbo, MD
    The measurement of blood pressure is used to determine if a person has abnormal blood pressure, usually high blood pressure (also known as hypertension) and whether their blood pressure is controlled while taking medications that lower blood pressure. For many people, current cuff-based blood pressure devices are uncomfortable, non-portable, and susceptible to various artifacts. An app-paired cuffless blood pressure device would enable semi-continuous blood pressure measurement without discomfort, but the accuracy of these devices is unclear. The purpose of this research is to compare the...

  • 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 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 sitting. Daily sedentary behavior is strongly associated with the risk of heart disease. The purpose of the BREAK II research study is to answer two questions: (1) How frequently 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 receive up to $...

  • 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 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...

  • 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...

  • Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism (HI-PEITHO)

    Principal Investigator:

    Sanjum Sethi, MD
    The purpose of this study is to determine whether treatment with anticoagulation medications incombination with the EkoSonicTM Endovascular device with a dose of a clot-dissolving drug(thrombolytic) can reduce the risk of death and other serious problems when compared to anticoagulation medication alone. Other measurements will be taken to observe your overall health and quality of life for one year after treatment.

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