Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
NCT00787293 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2011-02-14
Summary
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.
Conditions
- Heart Failure
- Mitral Regurgitation
Interventions
- DEVICE
-
PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.
Sponsors & Collaborators
- collaborator OTHER
-
Medifacts International Corporation
collaborator INDUSTRY -
Viacor
lead INDUSTRY
Principal Investigators
-
Stefan Sack, Md, PhD · Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH
-
Rainer Hoffmann, MD · R-WTH Universitätsklinikum Aachen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2010-11-30
- Completion
- 2015-11-30
Countries
- Belgium
- Czechia
- Germany
- Netherlands
- Switzerland
Study Locations
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