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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Trial of Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation on Functional Mitral Stenosis: The Canadian Mitral Research Alliance (CAMRA-1) Trial

Brief 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.

Detailed Summary: 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.
Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: Mean mitral valve gradient at peak exercise 12-months following repair [ Time Frame: 12 months following repair ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mitral valve area [ Time Frame: 12 months following repair ]
  • Age/Sex predicted metabolic equivalent score [ Time Frame: 12 months following repair ]
  • Mitral leaflet coaptation height [ Time Frame: 12 months following repair ]
  • 6-minute walk test [ Time Frame: 12 months following repair ]
  • Composite MACE (major adverse cardiovascular event) end-point of recurrent MR ≥2+, death, or hospital re-admission for congestive heart failure within 12-months of surgery [ Time Frame: 12 months following repair ]


Original Secondary Outcome: Same as current

Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: July 30, 2015
Date Started: January 2016
Date Completion: December 2018
Last Updated: February 3, 2017
Last Verified: February 2017