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MitraClip® Registry

Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie (Other)
Overall Status
Recruiting
CT.gov ID
NCT02033811
Collaborator
(none)
200
Enrollment
1
Location
203
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System
    Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2030
    Anticipated Study Completion Date :
    Dec 1, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Major cardiac adverse events [30 days]

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

    Secondary Outcome Measures

    1. Mortality [1 year]

      Proportion of patients who are alive at 1 year after receiving

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine Dusseldorf Germany 40225

    Sponsors and Collaborators

    • Klinik für Kardiologie, Pneumologie und Angiologie

    Investigators

    • Principal Investigator: Malte Kelm, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine
    • Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Klinik für Kardiologie, Pneumologie und Angiologie, Director Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT02033811
    Other Study ID Numbers:
    • MitraClip® Registry
    First Posted:
    Jan 13, 2014
    Last Update Posted:
    Feb 7, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Director Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University, Duesseldorf
    mitral regurgitation
    MitraClip system
    percutaneous mitral valve repair
    Additional relevant MeSH terms:
    Mitral Valve Insufficiency

    Study Results

    No Results Posted as of Feb 7, 2020