Clincosm LogoSign in Get a demo

IPPVM: Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT03113552
Collaborator
(none)
348
Enrollment
1
Location
148.9
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    348 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty
    Actual Study Start Date :
    Feb 4, 2013
    Anticipated Primary Completion Date :
    Jul 4, 2025
    Anticipated Study Completion Date :
    Jul 4, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Survival defines as the time between the date of surgery and the death or date of the last news [6 months]

    Eligibility Criteria

    Criteria

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

    • Patients operated between 1988 and 2011

    • Presence of a valvular prolapse diagnosed by echocardiography

    • Possibility of a complete clinical evaluation at the time of the initial echocardiography

    Exclusion Criteria:

    • Ischemic MI (including papillary muscle rupture)

    • Presence of significant aortic valvulopathy, mitral valvular stenosis or congenital disease

    • History of cardiac surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Picardie Amiens Picardie France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT03113552
    Other Study ID Numbers:
    • PI2013_843_0002
    First Posted:
    Apr 13, 2017
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mitral Valve Prolapse
    Prolapse

    Study Results

    No Results Posted as of Jul 7, 2021