Mitral Valve Disease clinical trials at UC Health

• 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. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-randomized cohort. 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 UCSF

• 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

Last updated: November 2, 2020