Safety and Efficacy clinical trial of the PTMA System to reduce mitral valve regurgitation in heart failure.
Recruiting
- Conditions
- Heart failure, Mitral valve, Mitral valve insufficiency, Mitral regurgitation, Valve disease
- Registration Number
- NL-OMON20121
- Lead Sponsor
- Viacor, Inc.
- Brief Summary
http://www.viacorinc.com/bibliography.html
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Moderate functional MR
2. Symptomatic heart failure
Exclusion Criteria
1. MR of organic origins
2. Severe mitral leaflet tethering
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Safety: freedom from MACE rate<br /><br>- Efficacy: Quantitative MR reduction at 6 months and device success.
- Secondary Outcome Measures
Name Time Method - Safety<br /><br>- Efficacy