I34.0
Conditions
Interventions
Group 1: This is an observational study and will evaluate results by comparing pre-operative measurements to post-operative measurements
Sponsors
Corporate Sponsor
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Inclusion criteria
Inclusion criteria: a) Patient is 21 years of age or older. b) Patient has symptomatic moderate to severe (3+ MR) or severe (4+ MR), chronic, mitral regurgitation c) Patient is a candidate for mitral valve repair surgery with cardiopulmonary bypass with or without concomitant cardiac surgeries, such as CABG, MAZE, or surgical treatment of other valves. d) Mitral regurgitation must meet the following criteria: i. The primary regurgitant jet is central, originating from mal coaptation of anterior and posterior leaflets of the mitral valve. ii. If a secondary jet is present, the jet must be considered clinically insignificant. e) Women of child-bearing potential have a negative pregnancy test.
Exclusion criteria
Exclusion criteria: a) Evidence of severe mitral annular and leaflet calcification. b) Patient is hemodynamically unstable. c) Patient has Left Ventricular Dysfunction as defined by EF70mm d) Patient has hypertrophic cardiomyopathy and has systolic anterior motion of the leaflets. e) Patient requires emergency surgery. f) Patient has echocardiographic evidence of endocarditis or rheumatic heart disease. g) Transesophageal Echocardiogram (TEE) is contraindicated or cannot be performed intraoperatively for any reason. h) Patient has known chronic, dialysis-dependent renal failure. i) History of stroke, TIA or reversible ischemic neurological disease within the last three (3) months. j) History of gastrointestinal bleeding within the last three (3) months. k) History of hypersensitivity or allergy to aspirin l) History or hypersensitivity to clopidogrel (Plavix) or its congeners. m) Active or treated malignancies in the last twelve (12) months. n) Patient is participating in another clinical study for which follow-up is currently ongoing. o) Women of child-bearing age who have not had a negative pregnancy test. p) Patient with non-cardiac co-morbidities and life expectancy < 1 year. q) Patient has a condition that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Mitral Regurgitation from baseline to 6 months by TTE (transthoracic echocardiogram) evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Preservation/improvement in Left Ventricular health (dimensions, volume, etc.) based on changes in NYHA (New York Heart Association) status and TTE | — |
Countries
Czechia, Germany
Contacts
Public ContactMarianne Baldwin
VP RA/CA/QAHeart Repair Technologies, Inc.
Outcome results
None listed