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MitraClip: Transcatheter Mitral Valvuloplasty Pilot Study

Sponsor
Duk-Woo Park, MD (Other)
Overall Status
Completed
CT.gov ID
NCT04351984
Collaborator
CardioVascular Research Foundation, Korea (Other)
5
Enrollment
1
Location
14.4
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation

Condition or Disease Intervention/Treatment Phase
  • Device: MitraClip

Study Design

Study Type:
Observational
Actual Enrollment :
5 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study
Actual Study Start Date :
Oct 20, 2020
Actual Primary Completion Date :
Dec 16, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Severe Mitral Regurgitation

Device: MitraClip
Transcatheter Mitral Valvuloplasty with MitraClip
Other Names:
  • Transcatheter Mitral Valvuloplasty

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mitral regurgitation [1 month]

    Secondary Outcome Measures

    1. All cause death [1 year]

    2. Stroke [1 year]

    3. Myocardial infarction [1 year]

    4. Re-hospitalization [1 year]

    5. Acute kidney dysfunction [5 days]

    6. Vascular complication [5 days]

    7. Bleeding [5 days]

    8. Successful valvuloplasty [5 days]

      No significant complication

    Eligibility Criteria

    Criteria

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

    • Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

    • Age 19 and more

    • Written informed consent

    Exclusion Criteria:

    • Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen

    • Active endocarditis of the mitral valve

    • Rheumatic mitral valve disease

    • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Duk-Woo Park, MD
    • CardioVascular Research Foundation, Korea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duk-Woo Park, MD, Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT04351984
    Other Study ID Numbers:
    • AMCCV2020-04
    First Posted:
    Apr 17, 2020
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Duk-Woo Park, MD, Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center
    MitraClip
    Additional relevant MeSH terms:
    Mitral Valve Insufficiency

    Study Results

    No Results Posted as of Feb 24, 2022