Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients - Full Text View

Sponsors and Collaborators:	Viacor Duke Clinical Research Organization Medifacts International
Information provided by:	Viacor
ClinicalTrials.gov Identifier:	NCT00787293

Purpose

Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.

Condition	Intervention	Phase
Heart Failure Mitral Regurgitation	Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant	Phase II

MedlinePlus related topics: Heart Failure

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

Further study details as provided by Viacor:

Primary Outcome Measures:

Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months [ Time Frame: 30 days to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

% of patients experiencing procedure or device-related adverse events [ Time Frame: 30 days to 6 months ] [ Designated as safety issue: Yes ]
Technical procedural success: % of patients maintaining a reduction of mitral annulus A/P dimension, sustained MR reduction, and decrease in left ventricular dimensions to specified degrees [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical status: % of treated patients exhibiting improvements in defined QoL parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2008

Arms	Assigned Interventions
1: Experimental Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.	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.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787293

Contacts

Contact: Katharine M. Stohlman

978-657-5099 ext 130

Locations

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

Sponsors and Collaborators

Viacor

Duke Clinical Research Organization

Medifacts International

Investigators

Principal Investigator:

Stefan Sack, Md, PhD

Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH

More Information

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

Keywords provided by Viacor:

Heart Failure
Mitral Regurgitation

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009