Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation
Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation
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.
Inclusion Criteria:

 -  Patients moderate to severe, symptomatic functional (ischemic or dilated
 cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of
 the mitral annulus who qualify for mitral valve repair with cardiopulmonary bypass

 -  Mitral regurgitation must meet the following criteria:

 -  The primary regurgitant jet is central, originating from mal coaptation of anterior
 and posterior leaflets of the mitral valve.

 -  If a secondary jet is present, the jet must be considered clinically insignificant.

 -  Women of child-bearing potential have a negative pregnancy test

 Exclusion Criteria:

 -  Evidence of severe mitral annular and leaflet calcification.

 -  Patient is hemodynamically unstable.

 -  Patient has hypertrophic cardiomyopathy and has systolic anterior motion of the
 leaflets.

 -  Patient requires emergency surgery.

 -  Patient has echocardiographic evidence of endocarditis or rheumatic heart disease.

 -  Transesophageal Echocardiogram (TEE) is contraindicated or cannot be performed
 intraoperatively for any reason.

 -  Patient has known chronic, dialysis-dependent renal failure.

 -  History of stroke, transient ischemic attack (TIA) or reversible ischemic neurological
 disease within the last three (3) months.

 -  History of gastrointestinal bleeding within the last three (3) months.

 -  History of hypersensitivity or allergy to aspirin

 -  History or hypersensitivity to clopidogrel (Plavix) or its congeners.

 -  Active or treated malignancies in the last twelve (12) months.

 -  Patient is participating in another clinical study for which follow-up is currently
 ongoing.

 -  Women of child-bearing age who have not had a negative pregnancy test.

 -  Patient with non-cardiac co-morbidities and life expectancy < 1 year.

 -  Patient has a condition that, in the opinion of the Investigator, precludes
 participation, including willingness to comply with all follow-up procedures.