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Sponsors and Collaborators: |
Viacor Duke Clinical Research Organization Medifacts International |
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Information provided by: | Viacor |
ClinicalTrials.gov Identifier: | NCT00787293 |
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.
Condition | Intervention | Phase |
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Heart Failure Mitral Regurgitation |
Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
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 assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Katharine M. Stohlman | 978-657-5099 ext 130 | kstohlman@viacorinc.com |
Germany | |
Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen | Recruiting |
Essen, Germany, 45122 | |
Contact: Raimund Erbel, Md, PhD +49 201 723 4800 erbel@uk-essen.de | |
Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen | Recruiting |
Aachen, Germany, 52074 | |
Contact: Rainer Hoffmann, MD +49 241 808 9705 rhoffmann@ukaachen.de |
Principal Investigator: | Stefan Sack, Md, PhD | Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH |
Responsible Party: | Viacor, Inc. ( Katharine M Stohlman ) |
Study ID Numbers: | 08-010P |
Study First Received: | November 5, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00787293 |
Health Authority: | Germany: Ethics Commission |
Heart Failure Mitral Regurgitation |
Heart Failure Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency |
Cardiovascular Diseases |