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Clinical Trials/NCT02033811
NCT02033811
Recruiting
Not Applicable

MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System

Klinik für Kardiologie, Pneumologie und Angiologie1 site in 1 country200 target enrollmentJanuary 2014
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ConditionsMitral Regurgitation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Enrollment
200
Locations
1
Primary Endpoint
Major cardiac adverse events
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2030
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Responsible Party
Sponsor Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Director Division of Cardiology, Pulmonary Disease and Vascular Medicine

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

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

Outcomes

Primary Outcomes

Major cardiac adverse events

Time Frame: 30 days

increase in the 30-day risk of adverse events among patients receiving PMVR

Secondary Outcomes

  • Mortality(1 year)

Study Sites (1)

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