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

Phase 1

Completed

• Conditions: Heart Failure; Mitral Regurgitation

• Registration Number: NCT00572091
• Lead Sponsor: Viacor

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-12-10
• 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: 4

Inclusion Criteria

• Symptomatic heart failure
• functional MR 2+ - 4+
• LVEF 20% - 50%

Exclusion Criteria

• MR of organic origins
• significant co-morbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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 mitral regurgitation and reduction in mitral anterior posterior dimension	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.	30 days

Trial Locations

Locations (1)

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