Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Phase 1
Completed
- Conditions
- Heart FailureMitral Regurgitation
- Interventions
- Device: PTMA Implant
- Registration Number
- NCT00572091
- Lead Sponsor
- Viacor
- Brief Summary
Improvement in 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
- 4
Inclusion Criteria
- Symptomatic heart failure
- functional MR 2+ - 4+
- LVEF 20% - 50%
Exclusion Criteria
- MR of organic origins
- significant co-morbidities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 PTMA 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 in mitral anterior posterior dimension 30 days improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max. 30 days
Trial Locations
- Locations (1)
Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen
🇩🇪Aachen, Germany