Mitral Regurgitation Clinical Trial
Official title:
HRT Observational Study of a Mitral Bridge in Patients With Moderate to Severe Mitral Valve Regurgitation to Evaluate Device Safety and Performance
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation.
The primary objective of this study is to evaluate the safety and performance of the Mitral
Bridge device in the correction of mitral valve regurgitation in patients who qualify for
mitral valve repair as defined by the American Society of Echocardiography (ASE). The device
is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the
septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and
restraining the leaflets below the intra-annular plane.
The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to
follow the enrolled patients for a total of 5 years.
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|---|---|---|---|
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Phase 2 |