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CHOICE-MI: CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT04688190
Collaborator
Montreal Heart Institute (Other), University Hospital, Bordeaux (Other)
800
Enrollment
26
Locations
122
Anticipated Duration (Months)
30.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry
    Actual Study Start Date :
    Nov 1, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Dec 31, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Transcatheter Mitral Valve Implantation (TMVI)

    Patients with successful TMVI screening, who underwent Transcatheter Mitral Valve Implantation subsequently. All devices may be included.
    Interventional mitral valve edge-to-edge repair (E2E)

    Patients with TMVI screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair.
    Mitral valve surgery (Surgery)

    Patients with TMVI screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement).
    Medical therapy (OMT)

    Patients with TMVI screening failure, who subsequently underwent conservative or optimal medical therapy (OMT).

    Outcome Measures

    Primary Outcome Measures

    1. Mitral insufficiency grade 2+ or more [12 months]

      Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.

    2. Freedom from device-related complications [30 days]

    Secondary Outcome Measures

    1. Combined all-cause mortality or rehospitalization for congestive heart failure [12 months]

    2. All-cause mortality [12 months]

    3. Cardiovascular mortality [12 months]

    4. Rehospitalization for congestive heart failure [12 months]

      Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.

    5. Combined cardiovascular mortality or rehospitalization for congestive heart failure [12 months]

    6. Unplanned mitral valve intervention [12 months]

      Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation, e.g. as assessed by patient interviews.

    7. Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention [12 months]

    8. Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention [12 months]

    9. New York Heart Association (NYHA) stage III or IV [12 months]

      Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.

    Eligibility Criteria

    Criteria

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

    • clinically significant mitral insufficiency

    • patient underwent screening for TMVI

    • echocardiography data at baseline (and after TMVI, E2E and surgery)

    • follow-up of at least 30 days

    Exclusion Criteria:
    • age under 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center, Los Angeles Los Angeles California United States 90048
    2 Brigham and Women's Hospital Boston Massachusetts United States 02115
    3 Houston Methodist Hospital Houston Texas United States 77030
    4 St Vincent's Hospital Sydney Australia
    5 Toronto Heart Center Toronto Canada
    6 St. Paul's Hospital Vancouver Canada
    7 Rigshospitalet Copenhagen Denmark
    8 CHU Bordeaux Bourdeaux France
    9 Lille University Hospital Lille France
    10 Civils Hospices of Lyon Lyon France
    11 Clinique Pasteur Toulouse France
    12 HDZ Bad Oeynhausen Bad Oeynhausen Germany
    13 German Heart Center Berlin Berlin Germany
    14 Heart Center Bonn Bonn Germany
    15 University Hospital of Cologne Cologne Germany
    16 Goethe-Universität - University Hospital Frankfurt Frankfurt Germany
    17 University Heart and Vascular Center Hamburg Hamburg Germany
    18 Heart Center of the University Medical Center Mainz Mainz Germany
    19 German Heart Centre Munich Munich Germany
    20 LMU Munich Munich Germany
    21 San Raffaele University Hospital Milan Italy
    22 Rikshospitalet, Oslo University Hospital (OUS) Oslo Norway
    23 Inselspital Bern Bern Switzerland
    24 USZ Zurich Zürich Switzerland
    25 Royal Brompton Hospital London United Kingdom
    26 St Thomas' Hospital - London London United Kingdom

    Sponsors and Collaborators

    • Universitätsklinikum Hamburg-Eppendorf
    • Montreal Heart Institute
    • University Hospital, Bordeaux

    Investigators

    • Principal Investigator: Lenard Conradi, MD, University Heart and Vascular Center Hamburg
    • Principal Investigator: Thomas Modine, MD, University Hospital, Bordeaux
    • Principal Investigator: Sebastian Ludwig, MD, University Heart and Vascular Center Hamburg
    • Principal Investigator: Walid Ben Ali, MD, Montreal Heart Institute
    • Principal Investigator: Alison Duncan, MD, Royal Brompton Hospital London
    • Principal Investigator: Gilbert Tang, MD, Mount Sinai Medical Center, NYC
    • Principal Investigator: Juan F Granada, MD, Cardiovascular Research Foundation, New York, USA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sebastian Ludwig, Sebastian Ludwig, M.D., Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
    ClinicalTrials.gov Identifier:
    NCT04688190
    Other Study ID Numbers:
    • CHOICE-MI
    First Posted:
    Dec 29, 2020
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mitral Valve Insufficiency

    Study Results

    No Results Posted as of May 17, 2022