MitraClip® Registry

Recruiting

• Conditions: Mitral Regurgitation

• Registration Number: NCT02033811
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Brief Summary

Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.

The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• severe mitral regurgitation
• percutaneous mitral valve repair (PMVR) with the MitraClip® system

Exclusion Criteria

• < 18 years
• Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major cardiac adverse events	30 days	increase in the 30-day risk of adverse events among patients receiving PMVR

Secondary Outcome Measures

Name	Time	Method
Mortality	1 year	Proportion of patients who are alive at 1 year after receiving

Trial Locations

Locations (1)

Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine; 🇩🇪 Dusseldorf, Germany