Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients

Phase 2

Suspended

• Conditions: Heart Failure; Mitral Regurgitation

• Registration Number: NCT00787293
• Lead Sponsor: Viacor

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-07
• Primary Completion: 2010-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-14
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Functional MR 2+ - 4+
• Symptomatic heart failure, NYHA Class II to IV
• LVEF > 25% or < 50% OR dilated mitral annulus > 30mm

Exclusion Criteria

• MR of organic origin
• Severe mitral leaflet tethering
• History of MI or PCI within 60 days of study procedure
• Inability to walk a minimum of 100 meters in 6 minutes
• Significant left main stenosis or proximal circumflex stent
• Indication of non-patent CSO or discontinuous CS-GCV-AIV
• Bi-ventricular with leads in CS or other devices impeding device placement
• Severe aortic valvular disease
• Chronic corticosteroid use other than < 20mg prednisone for arthritis
• Significant co-morbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months	30 days to 6 months

Secondary Outcome Measures

Name	Time	Method
% of patients experiencing procedure or device-related adverse events	30 days to 6 months
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	6 months
Clinical status: % of treated patients exhibiting improvements in defined QoL parameters	6 months

Trial Locations

Locations (13)

Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst; 🇧🇪 Aalst, Belgium

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

Institut Klinicke a Experimentalni Mediciny; 🇨🇿 Prague, Czech Republic

Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen; 🇩🇪 Aachen, Germany

Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum; 🇩🇪 Bad Oeynhausen, Germany

Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

CardioVascular Center Frankfurt Sankt Katharinen; 🇩🇪 Frankfurt, Germany

Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg; 🇩🇪 Freiburg im Breisgau, Germany

Städtische Klinikum Karlsruhe GmbH; 🇩🇪 Karlsruhe, Germany

Klinikum Schwabing Städtisches Klinikum München GmbH; 🇩🇪 München, Germany

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