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Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Primary Purpose

Tricuspid Valve Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tricuspid annuloplasty
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Valve Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients undergoing mitral valve surgery with less than sever tricuspid insufficiency

Exclusion Criteria:

  • presence of pacemaker lead through the tricuspid valve
  • acute endocarditis
  • minimally invasive approach
  • Functional mitral valve insufficiency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Tricuspid annuloplasty

    No Tricuspid annuloplasty

    Arm Description

    Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery

    Control patients

    Outcomes

    Primary Outcome Measures

    Incidence of more than mild tricuspid insufficiency

    Secondary Outcome Measures

    VO2 max
    Physical function capacity measured by VO2 max
    Right ventricular function
    Right ventricle function at the follow up

    Full Information

    First Posted
    July 11, 2018
    Last Updated
    July 19, 2018
    Sponsor
    Université Catholique de Louvain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03604484
    Brief Title
    Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
    Official Title
    Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2009 (Actual)
    Primary Completion Date
    December 31, 2010 (Actual)
    Study Completion Date
    January 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université Catholique de Louvain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.
    Detailed Description
    The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures. A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta >3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tricuspid Valve Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tricuspid annuloplasty
    Arm Type
    Active Comparator
    Arm Description
    Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery
    Arm Title
    No Tricuspid annuloplasty
    Arm Type
    No Intervention
    Arm Description
    Control patients
    Intervention Type
    Procedure
    Intervention Name(s)
    Tricuspid annuloplasty
    Intervention Description
    Tricuspid annuloplasty
    Primary Outcome Measure Information:
    Title
    Incidence of more than mild tricuspid insufficiency
    Time Frame
    5 year
    Secondary Outcome Measure Information:
    Title
    VO2 max
    Description
    Physical function capacity measured by VO2 max
    Time Frame
    1 year
    Title
    Right ventricular function
    Description
    Right ventricle function at the follow up
    Time Frame
    5 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients undergoing mitral valve surgery with less than sever tricuspid insufficiency Exclusion Criteria: presence of pacemaker lead through the tricuspid valve acute endocarditis minimally invasive approach Functional mitral valve insufficiency

    12. IPD Sharing Statement

    Learn more about this trial

    Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

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