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Sponsored by: |
Viacor |
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Information provided by: | Viacor |
ClinicalTrials.gov Identifier: | NCT00571610 |
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
Condition | Intervention | Phase |
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Heart Failure Mitral Regurgitation |
Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve Regurgitation. |
Enrollment: | 5 |
Study Start Date: | April 2006 |
Study Completion Date: | November 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
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Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.
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Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Viacor, Inc. ( Katharine M Stohlman ) |
Study ID Numbers: | 05-020P |
Study First Received: | November 30, 2007 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00571610 |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
Heart Failure Mitral Regurgitation |
Heart Failure Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency |
Cardiovascular Diseases |