ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02552771
Recruitment Status : Recruiting
First Posted : September 17, 2015
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Ottawa Heart Institute Research Corporation
London Health Sciences Centre
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Mitral Valve Prolapse Procedure: Mitral repair with leaflet preservation Procedure: Mitral repair with leaflet resection Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




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

Secondary Outcome Measures :
  1. Mitral valve area [ Time Frame: 12 months following repair ]
  2. Age/Sex predicted metabolic equivalent score [ Time Frame: 12 months following repair ]
  3. Mitral leaflet coaptation height [ Time Frame: 12 months following repair ]
  4. 6-minute walk test [ Time Frame: 12 months following repair ]
  5. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552771


Contacts
Contact: Subodh Verma, MD 416-864-5997 vermasu@smh.ca
Contact: David Mazer, MD 416-864-5825 mazerd@smh.ca

Locations
Canada, Newfoundland and Labrador
Memorial University Not yet recruiting
St. John's, Newfoundland and Labrador, Canada
Contact: Corey Adams, MD    709-777-2296      
Principal Investigator: Corey Adams, MD         
Canada, Ontario
Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Victor Fan Chu, MD    1 905 523-0440    chu@HHSC.CA   
Contact: Richard Whitlock, MD       Richard.Whitlock@phri.ca   
Principal Investigator: Victor Fan Chu, MD         
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Michael Chu, MD    (519) 663-3593    Michael.Chu@lhsc.on.ca   
Contact: Stephanie Fox    519-685-8500 ext 35031    Stephanie.Fox@lhsc.on.ca   
Principal Investigator: Michael Chu, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Vincent Chan, MD    613-798-5555 ext 14253    VChan@ottawaheart.ca   
Contact: Jacqueline Fortier, Msc    613-798-5555 ext 18329    JFortier@ottawaheart.ca   
Principal Investigator: Vincent Chan, MD         
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Subodh Verma, MD    (416) 864-5997    vermasu@smh.ca   
Contact: Sanjay Yagnik    416-864-6060 ext 6690    YagnikS@smh.ca   
Principal Investigator: Subodh Verma, MD         
Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Benoit de Varennes, MD    514-934-1934 ext 34980    benoit.devarennes@muhc.mcgill.ca   
Contact: Carole Albert    514-934-1934 ext 35277    carole.albert@muhc.mcgill.ca   
Principal Investigator: Benoit de Varennes, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Ottawa Heart Institute Research Corporation
London Health Sciences Centre
Investigators
Principal Investigator: Vincent Chan, MD Ottawa Heart Institute Research Corporation
Principal Investigator: Subodh Verma, MD St. Michael's Hospital, Toronto

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02552771     History of Changes
Other Study ID Numbers: 15-162
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Prolapse
Mitral Valve Prolapse
Pathological Conditions, Anatomical
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases