Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device

Phase 1

Completed

• Conditions: Heart Failure; Mitral Regurgitation
• Interventions: Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

• Registration Number: NCT00571610
• Lead Sponsor: Viacor

Brief Summary

Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-12
• Primary Completion: 2008-04
• Status Verified: 2008-11
• Study Completion: 2008-11
• Last Update Submitted: 2008-11-05
• Last Update Posted: 2008-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Functional MR 2+ - 4+ with left ventricular enlargement
• Symptomatic heart failure
• 20% - 50% LVEF

Exclusion Criteria

• mitral regurgitation of organic origins
• recent cardiac interventions
• severe comorbidities

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. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.

Primary Outcome Measures

Name	Time	Method
percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery	30 days

Secondary Outcome Measures

Name	Time	Method
percent of implanted patients who maintain a sustained 1 grade reduction in MR and reduction of mitral annulus anterior posterior dimension	30 days
percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max	30 days

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada