heartvalve dysfunction mitralis regurgitation
Conditions
Interventions
Implant Edwards Monarc Lifesciences system
Sponsors
Edwards Lifesciences SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - functional mitral valve regurgitation - ischemic or idiopathic cardiomyopathy - NYHA Class II-IV - Moderatre to severe mitral regurgitation - Ability to perform 6 minute walk: 150-450 meters
Exclusion criteria
Exclusion criteria: - subjects who are eligible for biventricular pacing leads within the coronary sinus - active endocarditis - prior mitral valve repair of replacement - serum creatinine leven > 2.0mg/dl - allergy to anticoagulation medications or contrast media - aortic valve disease that requires surgical intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is the individual rate of the following events: Death, Myocardial Infarction (Q-wave or Non-Q-wave having total CK >2X normal with any CKMB > normal or elevated Troponin above institution*s upper level) and Cardiac tamponade within 30 days of date of implantation. The primary efficacy endpoint is the percentage of subjects with a one-grade or greater reduction in severity of mitral regurgitation at 6 and 12 months (compared to baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with MR severity of 2+ of less. Percentage of subjects with a one-grade of greater reduction in severity of mitralregurgitation. Frequency of rehospitalization for CHF. Hemodynamic Parameters Evaluation via TTE. Clinical funcionale status evaluation. Quality of Life Assessment. | — |
Countries
Netherlands
Outcome results
None listed