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MITIGATE: Evaluation of Mitral Valve Insufficiency Under General Anesthesia

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05736289
Collaborator
(none)
50
Enrollment
28.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. Investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and after mitral valve intervention using Nexfin (BMEYE, Amsterdam, the Netherlands) continuous non-invasive hemodynamic monitoring, using finger cuff based technology to register beat-to-beat data

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Mitral Valve Insufficiency Under General Anesthesia
    Anticipated Study Start Date :
    Feb 13, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Percutaneous mitral valve repair

    Patients undergoing percutaneous mitral valve repair under general anesthesia for mitral valve regurgitation.
    Surgical mitral valve repair or replacement

    Patients undergoing surgical mitral valve repair or replacement for mitral valve regurgitation.

    Outcome Measures

    Primary Outcome Measures

    1. Arterial pressure waveform changes [Before and during general anesthesia for mitral valve repair or replacement, ranging from 1 to 5 hours.]

      Arterial pressure waveform as recorded by a continuous non invasive hemodynamic monitoring system.

    Eligibility Criteria

    Criteria

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

    • All patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for this condition

    • Adult patients (>18 years)

    Exclusion Criteria:
    • No informed consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Investigators

    • Principal Investigator: Denise P Veelo, MD PhD, Amsterdam University Medical Center - University of Amsterdam

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Denise P. Veelo, Principal Investigator, Associate Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT05736289
    Other Study ID Numbers:
    • W22_423
    First Posted:
    Feb 21, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    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
    Additional relevant MeSH terms:
    Mitral Valve Insufficiency

    Study Results

    No Results Posted as of Feb 21, 2023