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

December 5, 2018 updated by: Unity Health Toronto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Subodh Verma, MD
  • Phone Number: 416-864-5997
  • Email: vermasu@smh.ca

Study Contact Backup

  • Name: David Mazer, MD
  • Phone Number: 416-864-5825
  • Email: mazerd@smh.ca

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Not yet recruiting
        • Memorial University
        • Contact:
          • Corey Adams, MD
          • Phone Number: 709-777-2296
        • Principal Investigator:
          • Corey Adams, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Not yet recruiting
        • Hamilton General Hospital
        • Contact:
          • Victor Fan Chu, MD
          • Phone Number: 1 905 523-0440
          • Email: chu@HHSC.CA
        • Contact:
        • Principal Investigator:
          • Victor Fan Chu, MD
      • London, Ontario, Canada, N6A 5W9
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5B1W8
        • Recruiting
        • St Michael's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Subodh Verma, MD
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with mitral regurgitation and mitral valve prolapse who are scheduled for elective mitral valve repair by an experienced mitral valve repair surgeon (>15 degenerative mitral valve repairs per year, with a repair rate>90%, and able to perform mitral repair with either a leaflet resection or leaflet preservation strategy).
  2. Planned mitral valve repair amenable to either a leaflet resection or leaflet preservation surgical repair strategy

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 one leaflet 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mitral repair with leaflet preservation
Placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle).
Procedure: Mitral repair with leaflet preservation
Placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle).
Active Comparator: Mitral repair with leaflet resection
Removal of one or both of the mitral leaflets that flop or bulge back.
Procedure: Mitral repair with leaflet resection
Removing one or both of the mitral leaflets that flop or bulge back.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean mitral valve gradient at peak exercise 12-months following repair
Time Frame: 12 months following repair
12 months following repair

Secondary Outcome Measures

Outcome Measure
Time Frame
Mitral valve area
Time Frame: 12 months following repair
12 months following repair
Age/Sex predicted metabolic equivalent score
Time Frame: 12 months following repair
12 months following repair
Mitral leaflet coaptation height
Time Frame: 12 months following repair
12 months following repair
6-minute walk test
Time Frame: 12 months following repair
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
12 months following repair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

London Health Sciences Centre
Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Subodh Verma, MD, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

December 7, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-162

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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