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Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04200378
Collaborator
(none)
52
Enrollment
1
Location
43.4
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Studying the effects of Trans-catheter Mitral Valve Repair (TMVr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    52 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair
    Actual Study Start Date :
    Aug 20, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Subjects undergoing TMVr

    Subjects with severe, symptomatic primary mitral regurgitation (MR) scheduled to undergo a transcatheter mitral valve repair (TMVr) as standard of care will have intra-op baseline and post repair blood draws. Pre-procedure and post-procedure transthoracic echocardiograms (TTE) will assess the hemodynamic implications of the repair.

    Outcome Measures

    Primary Outcome Measures

    1. Change in stroke volume index [Baseline, approximately 10 mins after valve repair]

      Change in stroke volume index 10 minutes post repair to baseline stroke volume index measurement (L/m^2)

    2. Change in cardiac index [Baseline, approximately 10 mins after valve repair]

      Change in cardiac index 10 minutes post repair to baseline cardiac index measurement (L/min/m^2)

    Eligibility Criteria

    Criteria

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

    • Adults (age ≥ 40 years) with severe, symptomatic primary mitral regurgitation identified by Doppler transthoracic echocardiogram

    • Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for TMVR with MitraClip

    • TMVR procedure will be performed in the cardiac catheterization laboratory for hemodynamic data recording

    Exclusion Criteria:
    • Women who are pregnant or believe they could be pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Mackram Eleid, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Mackram F. Eleid, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04200378
    Other Study ID Numbers:
    • 19-004449
    First Posted:
    Dec 16, 2019
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Aug 10, 2022