Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Phase 1
Completed
- Conditions
- Heart FailureMitral Regurgitation
- Interventions
- Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Registration Number
- NCT00568230
- Lead Sponsor
- Viacor
- Brief Summary
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- symptomatic heart failure
- moderate to severe mitral regurgitation
- 20 - 50% LVEF
Exclusion Criteria
- mitral regurgitation of organic origins
- recent interventions
- severe comorbidities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant Patient is screened for study, and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
- Primary Outcome Measures
Name Time Method percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery) 30 days
- Secondary Outcome Measures
Name Time Method percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction of mitral annulus anterior posterior dimension 30 days improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max 30 days
Trial Locations
- Locations (1)
Universitat Duisburg-Essen
🇩🇪Essen, Germany