The Canadian Mitral Research Alliance (CAMRA) Trial CardioLink-2

Last updated: December 5, 2018
Sponsor: St. Michael's Hospital, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Heart Defect

Treatment

N/A

Clinical Study ID

NCT02552771
15-162
  • All Genders

Study Summary

Multicentre, double-armed, randomized controlled trial designed to compare mitral valve leaflet resection versus leaflet preservation with regards to the development of functional mitral stenosis following surgical repair of mitral valve prolapse. Patients will be randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed by echocardiographic and clinical assessment at 12-months following surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with mitral regurgitation and mitral valve prolapse who are scheduled forelective mitral valve repair by an experienced mitral valve repair surgeon (>15degenerative mitral valve repairs per year, with a repair rate>90%, and able toperform mitral repair with either a leaflet resection or leaflet preservationstrategy).

  2. Planned mitral valve repair amenable to either a leaflet resection or leafletpreservation surgical repair strategy

Exclusion

Exclusion Criteria:

  1. Patients with anterior leaflet or commissural prolapse

  2. Patients with endocarditis or rheumatic mitral valve disease

  3. Patients with mitral annular calcification extending beyond the circumference of oneleaflet scallop

  4. Patients with significant LV dysfunction defined as a LVEF <40%

  5. Patients undergoing concomitant aortic valve surgery

  6. Patients unable to undergo bicycle ergometry

Study Design

Total Participants: 104
Study Start date:
January 01, 2016
Estimated Completion Date:
January 31, 2020

Study Description

Mitral valve repair has emerged as the preferred surgical treatment for mitral valve prolapse (MVP), a condition wherein the mitral valve does not close properly. One common strategy for mitral valve repair is leaflet resection, which involves removing part of one or both of the mitral leaflets that flop or bulge back (prolapse). Another strategy is leaflet preservation, which involves placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). While both strategies are routinely used and lead to successful mitral valve repair, there is no clear evidence as to whether one strategy is better than the other in terms of long term outcome. The purpose of this study is to determine if one repair strategy (leaflet resection versus leaflet preservation) leads to better longer term patient outcomes. A total of 88 patients from 6 Canadian centres will be randomly assigned to one of the two strategies. The primary outcome will be functional mitral stenosis (MS) as assessed by 12-month mean mitral valve pressure gradient at peak exercise.

Connect with a study center

  • Memorial University

    St. John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

  • St Michael's Hospital

    Toronto, Ontario M5B1W8
    Canada

    Active - Recruiting

  • McGill University Health Center

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.