Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Overview

De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in absence of significant TR. However, whether such a strategy of "prophylactic TVP" results in improved outcomes has not been shown to date by a prospective randomized study. The investigators goal is therefore to initiate such a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.

Full Title of Study: “Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

Interventions

  • Procedure: Tricuspid Valve Annuloplasty
    • Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery

Arms, Groups and Cohorts

  • Experimental: Tricuspid Valve Annuloplasty
    • Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty.
  • No Intervention: Conservative arm
    • Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to mitral valve surgery without concomitant tricuspid valve annuloplasty.

Clinical Trial Outcome Measures

Primary Measures

  • combination of all-cause mortality or heart failure hospitalisation
    • Time Frame: at 12 months post-surgery

Secondary Measures

  • RV function & geometry
    • Time Frame: 3, 6, 12 and 18 months
    • volumes and ejection fraction Assessed by cardiac ultrasound and MRI
  • Quality of Life
    • Time Frame: 6, 12 and 18 months
    • Change at follow-up, measured by SF-36 & Minnesota Living with Heart Failure scale.
  • Duration of Hospital and ICU stay
    • Time Frame: postoperative phase
  • All-Cause Mortality
    • Time Frame: at 3, 6, 12 and 18 months post-surgery
  • Hospitalization for Heart Failure
    • Time Frame: at 3, 6, 12 and 18 months post-surgery
  • progressive TR > 2+ post-surgery
    • Time Frame: 3, 6, 12 and 18 months
  • cardiovascular mortality
    • Time Frame: at 3, 6, 12 and 18 months post-surgery
  • Exercise Tolerance
    • Time Frame: 6, 12 and 18 months
    • Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)

Participating in This Clinical Trial

Inclusion Criteria

  • Scheduled for mitral valve surgery – Tricuspid Annular diameter > 40mm or >21mm/m² Exclusion Criteria:

  • Tricuspid Regurgitation more than 2+ – Unable to provide informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hasselt University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wilfried Mullens, MD PhD, Professor Cardiovascular Physiology – Hasselt University
  • Overall Contact(s)
    • David Verhaert, MD, +32 089 32 70 91, david.verhaert@zol.be

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