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
• Interventions: Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

• 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

Arm && Interventions

Group	Intervention	Description
1	PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant	Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system.

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)

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

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

Thoraxcentrum Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Netherlands

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

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

CardioVascular Center Frankfurt Sankt Katharinen; 🇩🇪 Frankfurt, Germany

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

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

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

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

Städtische Klinikum Karlsruhe GmbH; 🇩🇪 Karlsruhe, Germany

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

Hôpital Universitaire de Genève; 🇨🇭 Geneva, Switzerland