Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation

Viacor12 enrolled

Overview

Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.

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 with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * symptomatic heart failure * moderate to severe mitral regurgitation * 20 - 50% LVEF Exclusion Criteria: * mitral regurgitation of organic origins * recent interventions * severe comorbidities

Locations (1)

Universitat Duisburg-Essen

Essen, Germany

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 mitral regurgitation and reduction of mitral annulus anterior posterior dimension

Time frame: 30 days

improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max

Time frame: 30 days

Data from ClinicalTrials.gov

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