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Mitral Valve Disease clinical trials at UC Health
3 in progress, 1 open to eligible people

  • A Study of the Safety and Effectiveness of Experimental Tendyne Mitral Valve System for Mitral Regurgitation (backflow of blood)

    open to eligible people ages 18 years and up

    Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-Randomized and MAC cohorts will receive the trial device. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

    at UC Davis

  • HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

    Sorry, in progress, not accepting new patients

    The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm. 20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.

    at UC Davis

  • Natural History of Melody Valve in the Mitral and Tricuspid Position

    Sorry, in progress, not accepting new patients

    The Melody valve has historically been used for pulmonary valve replacements; however it has been more recently used in the mitral and tricuspid positions. This multi-center, retrospective, observational study will review the durability of the Melody valve inserted into the mitral or tricuspid positions. Patients who have undergone Melody valve insertion into either the mitral or tricuspid positions prior to December, 2014 will be eligible for the study. Basic de-identified patient demographics will be collected as well as select clinical data. Ventricular function and valvar function of the affected valve will be retrospectively reviewed both prior to surgery and following, as well as review of operative data. The investigators will also review the most recent follow up data and any subsequent re-interventions on the Melody valve. Data from all sites will be entered into an external REDCap database, using only de-identified data.

    at UCSF

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