Clinical Evaluation of the Edwards Lifesciences Monarc system for the treatment of Mitral Regurgitatio

Phase 2

Withdrawn

Conditions: heartvalve dysfunction
mitralis regurgitation
10046973

Registration Number: NL-OMON33127

Lead Sponsor: Edwards Lifesciences SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety endpoint is the individual rate of the following events:<br /><br>Death, Myocardial Infarction (Q-wave or Non-Q-wave having total CK >2X normal<br /><br>with any CKMB > normal or elevated Troponin above institution*s upper level)<br /><br>and Cardiac tamponade within 30 days of date of implantation.<br /><br>The primary efficacy endpoint is the percentage of subjects with a one-grade or<br /><br>greater reduction in severity of mitral regurgitation at 6 and 12 months<br /><br>(compared to baseline).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Percentage of subjects with MR severity of 2+ of less.<br /><br>Percentage of subjects with a one-grade of greater reduction in severity of<br /><br>mitralregurgitation.<br /><br>Frequency of rehospitalization for CHF.<br /><br>Hemodynamic Parameters Evaluation via TTE.<br /><br>Clinical funcionale status evaluation.<br /><br>Quality of Life Assessment.</p><br>