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

Phase 2CompletedNCT00572091

Viacor4 enrolled

Overview

Improvement in 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 ImplantDEVICE

Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic heart failure * functional MR 2+ - 4+ * LVEF 20% - 50% Exclusion Criteria: * MR of organic origins * significant co-morbidities

Locations (1)

Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

Aachen, 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 in mitral anterior posterior dimension

Time frame: 30 days

improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max.

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.