Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device

Phase 1CompletedNCT00571610

Viacor5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure Mitral Regurgitation

Interventions

PTMA (Percutaneous Transvenous Mitral Annuloplasty) ImplantDEVICE

Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Time frame: 30 days

Secondary Outcomes

percent of implanted patients who maintain a sustained 1 grade reduction in MR and reduction of mitral annulus anterior posterior dimension

Time frame: 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

Time frame: 30 days

Data from ClinicalTrials.gov

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