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| Name | Class |
|---|---|
| Ottawa Heart Institute Research Corporation | OTHER |
| London Health Sciences Centre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitral repair with leaflet preservation | Active Comparator | Placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). |
|
| Mitral repair with leaflet resection | Active Comparator | Removal of one or both of the mitral leaflets that flop or bulge back. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitral repair with leaflet preservation | Procedure | Placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean mitral valve gradient at peak exercise 12-months following repair | 12 months following repair |
| Measure | Description | Time Frame |
|---|---|---|
| Mitral valve area | 12 months following repair | |
| Age/Sex predicted metabolic equivalent score | 12 months following repair | |
| Mitral leaflet coaptation height |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Subodh Verma, MD | Contact | 416-864-5997 | vermasu@smh.ca | |
| David Mazer, MD | Contact | 416-864-5825 | mazerd@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Chan, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Subodh Verma, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial University | Not yet recruiting | St. John's | Newfoundland and Labrador | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15100753 | Background | Theal M, Sleik K, Anand S, Yi Q, Yusuf S, Lonn E. Prevalence of mitral valve prolapse in ethnic groups. Can J Cardiol. 2004 Apr;20(5):511-5. | |
| 10387935 | Background | Freed LA, Levy D, Levine RA, Larson MG, Evans JC, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical outcome of mitral-valve prolapse. N Engl J Med. 1999 Jul 1;341(1):1-7. doi: 10.1056/NEJM199907013410101. |
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| ID | Term |
|---|---|
| D008945 | Mitral Valve Prolapse |
| ID | Term |
|---|---|
| D016127 | Heart Valve Prolapse |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Mitral repair with leaflet resection | Procedure | Removing one or both of the mitral leaflets that flop or bulge back. |
|
| 12 months following repair |
| 6-minute walk test | 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 | 12 months following repair |
| Hamilton General Hospital | Not yet recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
|
| London Health Sciences Centre | Not yet recruiting | London | Ontario | N6A 5W9 | Canada |
|
| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
|
| St Michael's Hospital | Recruiting | Toronto | Ontario | M5B1W8 | Canada |
|
| McGill University Health Center | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
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| 40783073 | Derived | Rumman RK, Verma S, Chan V, Fottinger A, Quan A, Hibino M, de Varennes BE, Burns DJP, Chu MWA, Teoh H, Latter DA, Bisleri G, Leong-Poi H, Mazer CD, Connelly KA. Comparison of myocardial mechanics after mitral valve repair with leaflet preservation versus leaflet resection: A subanalysis of the randomized Canadian Mitral Research Alliance CardioLink-2 trial. J Thorac Cardiovasc Surg. 2026 Mar;171(3):604-612.e1. doi: 10.1016/j.jtcvs.2025.07.047. Epub 2025 Aug 7. |
| 36750353 | Derived | Rumman RK, Verma S, Chan V, Mazer D, Quan A, Hibino M, De Varennes B, Chu MWA, Latter D, Teoh H, Yanagawa B, Leong-Poi H, Connelly KA. Predictors of mitral valve haemodynamics after mitral valve repair for degenerative mitral regurgitation. Heart. 2023 May 15;109(11):866-873. doi: 10.1136/heartjnl-2022-321753. |
| 33017212 | Derived | Chan V, Mazer CD, Ali FM, Quan A, Ruel M, de Varennes BE, Gregory AJ, Bouchard D, Whitlock RP, Chu MWA, Dokollari A, Mesana T, Bhatt DL, Latter DA, Zuo F, Tsang W, Teoh H, Juni P, Leong-Poi H, Verma S. Randomized, Controlled Trial Comparing Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation on Functional Mitral Stenosis: The CAMRA CardioLink-2 Study. Circulation. 2020 Oct 6;142(14):1342-1350. doi: 10.1161/CIRCULATIONAHA.120.046853. Epub 2020 Oct 5. |
| 28566364 | Derived | Chan V, Chu MWA, Leong-Poi H, Latter DA, Hall J, Thorpe KE, de Varennes BE, Quan A, Tsang W, Dhingra N, Yared K, Teoh H, Chu FV, Chan KL, Mesana TG, Connelly KA, Ruel M, Juni P, Mazer CD, Verma S. Randomised trial of mitral valve repair with leaflet resection versus leaflet preservation on functional mitral stenosis (The CAMRA CardioLink-2 Trial). BMJ Open. 2017 May 30;7(5):e015032. doi: 10.1136/bmjopen-2016-015032. |