Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
NCT00568230 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2008-11-06
Summary
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.
Conditions
- Heart Failure
- Mitral Regurgitation
Interventions
- DEVICE
-
PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.
Sponsors & Collaborators
-
Viacor
lead INDUSTRY
Principal Investigators
-
Stefan Sack, MD · Universitat Duisburg-Essen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2008-04-30
- Completion
- 2008-11-30
Countries
- Germany
Study Locations
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