Mitral Valve Disease clinical trials at UC Health
2 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 two trial arms: surgical and non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial device or to conventional mitral valve surgery. Subjects in the non-surgical arm 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
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