Clinical Trials

  • Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)

    Principal Investigator:

    Sahil A. Parikh, MD
    This study aims to collect information about the symptoms and treatments of patients who have severely clogged arteries and are treated with commercially available Boston Scientific Corporation drug-eluting devices marketed for the treatment of lesions located in the peripheral vasculature. Participation in the study is expected to last for up to two (2). If you choose to be part of this research, we will ask you to be involved in routine follow-up visits at 6 months, 1 year, and every year thereafter for up to 2 years. Additionally, you may be asked to complete a survey before being treated...

  • Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial in Patients with Mitral Regurgitation

    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.

  • Guided Physiologic Stenting

    Principal Investigator:

    Megha Prasad, MD
    The primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI strategy; To establish the relationship between physiological guidance and improvement in associated angina and quality of life scores; To examine the outcomes in patients in whom an optimized post-PCI iFR can versus cannot be achieved.

  • IDH Mega Study

    Principal Investigator:

    Daichi Shimbo, MD
    The measurement of blood pressure is used to determine if a person has high blood pressure (also known as hypertension) and whether their blood pressure is controlled while taking medications that lower blood pressure. For many people, blood pressure levels are different when measured in a provider's office versus during normal daily activities outside of the office. There are two ways to measure blood pressure outside of the office: ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM). The best approach to measure blood pressure outside of the office is...

  • Medtronic Product Surveillance Registry Post Approval Network (PAN)

    Principal Investigator:

    Frederick Arthur Ehlert, MD
    The purpose of this registry is to collect information over time about how Medtronic products are working and/or the outcome of the treatment. The registry will be used to support post-market surveillance/monitoring activities and post-approval studies (e.g., to collect safety and performance information). In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines and patient services/solutions. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies...

  • MitraClip REPAIR MR Study in Patients with Primary Mitral Regurgitation

    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...

  • REACT-AF: Evaluation of Blood-Thinning Medication in Patients with Atrial Fibrillation (AF)

    Principal Investigator:

    Angelo Bartolo Biviano, MD
    The purpose of this study is to assess whether it is safe and effective to stop oral anticoagulation medication (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF). Atrial fibrillation (AF) is the most common abnormal heart rhythm and is associated with an increased risk of stroke, heart failure, and death.

  • REBIRTH - Study of Bromocriptine in Women with Peripartum Cardiomyopathy (PPCM)

    Principal Investigator:

    Jennifer Haden Haythe, MD
    We are doing this study to test the use of a drug called bromocriptine for women with a condition called Peripartum cardiomyopathy (PPCM). The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.

  • REBIRTH - Study of Bromocriptine in Women with Peripartum Cardiomyopathy (PPCM)

    Principal Investigator:

    Jennifer Haden Haythe, MD
    We are doing this study to test the use of a drug called bromocriptine for women with a condition called Peripartum cardiomyopathy (PPCM). The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.

  • Study of Aficamten in Patients with Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)

    Principal Investigator:

    Shepard D. Weiner, MD
    The purpose of this study is to compare the effects of Aficamten and placebo on health status and exercise capacity in participants with non-obstructive hypertrophic cardiomyopathy (nHCM). Participation in this research will involve up to 13 visits to the study site. The research study will last between 46 weeks (10.5 months) to at most 82 weeks (19 months). This time estimate includes the screening period (up to 6 weeks) to evaluate if you can participate in the study, the treatment period (36 to 72 weeks), and the follow-up period (of 4 weeks after the last treatment).

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