NCT02552771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

3 years

First QC Date

July 30, 2015

Last Update Submit

December 5, 2018

Conditions

Mitral Valve Prolapse

Outcome Measures

Primary Outcomes (1)

  • Mean mitral valve gradient at peak exercise 12-months following repair

    12 months following repair

Secondary Outcomes (5)

  • Mitral valve area

    12 months following repair

  • Age/Sex predicted metabolic equivalent score

    12 months following repair

  • Mitral leaflet coaptation height

    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

Study Arms (2)

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).

Procedure: Mitral repair with leaflet preservation

Mitral repair with leaflet resection

ACTIVE COMPARATOR

Removal of one or both of the mitral leaflets that flop or bulge back.

Procedure: Mitral repair with leaflet resection

Interventions

Mitral repair with leaflet preservationPROCEDURE

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 preservation
Mitral repair with leaflet resectionPROCEDURE

Removing one or both of the mitral leaflets that flop or bulge back.

Mitral repair with leaflet resection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Planned mitral valve repair amenable to either a leaflet resection or leaflet preservation surgical repair strategy

You may not qualify if:

  • Patients with anterior leaflet or commissural prolapse
  • Patients with endocarditis or rheumatic mitral valve disease
  • Patients with mitral annular calcification extending beyond the circumference of one leaflet scallop
  • Patients with significant LV dysfunction defined as a LVEF \<40%
  • Patients undergoing concomitant aortic valve surgery
  • Patients unable to undergo bicycle ergometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Memorial University

St. John's, Newfoundland and Labrador, Canada

NOT YET RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

NOT YET RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

NOT YET RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (32)

  • 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.

    PMID: 15100753BACKGROUND

  • 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.

    PMID: 10387935BACKGROUND

  • Flack JM, Kvasnicka JH, Gardin JM, Gidding SS, Manolio TA, Jacobs DR Jr. Anthropometric and physiologic correlates of mitral valve prolapse in a biethnic cohort of young adults: the CARDIA study. Am Heart J. 1999 Sep;138(3 Pt 1):486-92. doi: 10.1016/s0002-8703(99)70151-1.

    PMID: 10467199BACKGROUND

  • Ling LH, Enriquez-Sarano M, Seward JB, Tajik AJ, Schaff HV, Bailey KR, Frye RL. Clinical outcome of mitral regurgitation due to flail leaflet. N Engl J Med. 1996 Nov 7;335(19):1417-23. doi: 10.1056/NEJM199611073351902.

    PMID: 8875918BACKGROUND

  • Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.

    PMID: 15745978BACKGROUND

  • Verma S, Mesana TG. Mitral-valve repair for mitral-valve prolapse. N Engl J Med. 2009 Dec 3;361(23):2261-9. doi: 10.1056/NEJMct0806111. No abstract available.

    PMID: 19955526BACKGROUND

  • Chan V, Malas T, Lapierre H, Boodhwani M, Lam BK, Rubens FD, Hendry PJ, Masters RG, Goldstein W, Mesana TG, Ruel M. Reoperation of left heart valve bioprostheses according to age at implantation. Circulation. 2011 Sep 13;124(11 Suppl):S75-80. doi: 10.1161/CIRCULATIONAHA.110.011973.

    PMID: 21911822BACKGROUND

  • O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S23-42. doi: 10.1016/j.athoracsur.2009.05.056.

    PMID: 19559823BACKGROUND

  • Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3--valve plus coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S43-62. doi: 10.1016/j.athoracsur.2009.05.055.

    PMID: 19559824BACKGROUND

  • Ikonomidis JS, Kratz JM, Crumbley AJ 3rd, Stroud MR, Bradley SM, Sade RM, Crawford FA Jr. Twenty-year experience with the St Jude Medical mechanical valve prosthesis. J Thorac Cardiovasc Surg. 2003 Dec;126(6):2022-31. doi: 10.1016/j.jtcvs.2003.07.005.

    PMID: 14688722BACKGROUND

  • Chan V, Jamieson WR, Lam BK, Ruel M, Ling H, Fradet G, Mesana TG. Influence of the On-X mechanical prosthesis on intermediate-term major thromboembolism and hemorrhage: a prospective multicenter study. J Thorac Cardiovasc Surg. 2010 Nov;140(5):1053-8.e2. doi: 10.1016/j.jtcvs.2009.10.068. Epub 2010 May 23.

    PMID: 20546795BACKGROUND

  • Chan V, Ruel M, Elmistekawy E, Mesana TG. Determinants of left ventricular dysfunction after repair of chronic asymptomatic mitral regurgitation. Ann Thorac Surg. 2015 Jan;99(1):38-42. doi: 10.1016/j.athoracsur.2014.07.025. Epub 2014 Nov 6.

    PMID: 25442982BACKGROUND

  • Chan V, Ruel M, Hynes M, Chaudry S, Mesana TG. Impact of mitral annular calcification on early and late outcomes following mitral valve repair of myxomatous degeneration. Interact Cardiovasc Thorac Surg. 2013 Jul;17(1):120-5. doi: 10.1093/icvts/ivt163. Epub 2013 Apr 14.

    PMID: 23587525BACKGROUND

  • Chan V, Ruel M, Chaudry S, Lambert S, Mesana TG. Clinical and echocardiographic outcomes after repair of mitral valve bileaflet prolapse due to myxomatous disease. J Thorac Cardiovasc Surg. 2012 Apr;143(4 Suppl):S8-11. doi: 10.1016/j.jtcvs.2012.01.046. Epub 2012 Feb 4.

    PMID: 22306213BACKGROUND

  • Castillo JG, Anyanwu AC, Fuster V, Adams DH. A near 100% repair rate for mitral valve prolapse is achievable in a reference center: implications for future guidelines. J Thorac Cardiovasc Surg. 2012 Aug;144(2):308-12. doi: 10.1016/j.jtcvs.2011.12.054. Epub 2012 Jun 12.

    PMID: 22698565BACKGROUND

  • Carpentier A. Cardiac valve surgery--the "French correction". J Thorac Cardiovasc Surg. 1983 Sep;86(3):323-37. No abstract available.

    PMID: 6887954BACKGROUND

  • Braunberger E, Deloche A, Berrebi A, Abdallah F, Celestin JA, Meimoun P, Chatellier G, Chauvaud S, Fabiani JN, Carpentier A. Very long-term results (more than 20 years) of valve repair with carpentier's techniques in nonrheumatic mitral valve insufficiency. Circulation. 2001 Sep 18;104(12 Suppl 1):I8-11.

    PMID: 11568021BACKGROUND

  • Filsoufi F, Carpentier A. Principles of reconstructive surgery in degenerative mitral valve disease. Semin Thorac Cardiovasc Surg. 2007 Summer;19(2):103-10. doi: 10.1053/j.semtcvs.2007.04.003.

    PMID: 17870003BACKGROUND

  • Kuperstein R, Spiegelstein D, Rotem G, Stein M, Kogan A, Sternik L, Raanani E. Late clinical outcome of transient intraoperative systolic anterior motion post mitral valve repair. J Thorac Cardiovasc Surg. 2015 Feb;149(2):471-6. doi: 10.1016/j.jtcvs.2014.10.043. Epub 2014 Oct 14.

    PMID: 25454906BACKGROUND

  • Seeburger J, Falk V, Borger MA, Passage J, Walther T, Doll N, Mohr FW. Chordae replacement versus resection for repair of isolated posterior mitral leaflet prolapse: a egalite. Ann Thorac Surg. 2009 Jun;87(6):1715-20. doi: 10.1016/j.athoracsur.2009.03.003.

    PMID: 19463584BACKGROUND

  • Falk V, Seeburger J, Czesla M, Borger MA, Willige J, Kuntze T, Doll N, Borger F, Perrier P, Mohr FW. How does the use of polytetrafluoroethylene neochordae for posterior mitral valve prolapse (loop technique) compare with leaflet resection? A prospective randomized trial. J Thorac Cardiovasc Surg. 2008 Nov;136(5):1205; discussion 1205-6. doi: 10.1016/j.jtcvs.2008.07.028. Epub 2008 Sep 14.

    PMID: 19026803BACKGROUND

  • Lange R, Guenther T, Noebauer C, Kiefer B, Eichinger W, Voss B, Bauernschmitt R, Tassani-Prell P, Mazzitelli D. Chordal replacement versus quadrangular resection for repair of isolated posterior mitral leaflet prolapse. Ann Thorac Surg. 2010 Apr;89(4):1163-70; discussion 1170. doi: 10.1016/j.athoracsur.2009.12.057.

    PMID: 20338326BACKGROUND

  • Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):2438-88. doi: 10.1016/j.jacc.2014.02.537. Epub 2014 Mar 3. No abstract available.

    PMID: 24603192BACKGROUND

  • Chan KL, Chen SY, Chan V, Hay K, Mesana T, Lam BK. Functional significance of elevated mitral gradients after repair for degenerative mitral regurgitation. Circ Cardiovasc Imaging. 2013 Nov;6(6):1041-7. doi: 10.1161/CIRCIMAGING.112.000688. Epub 2013 Sep 6.

    PMID: 24014825BACKGROUND

  • Mesana TG, Lam BK, Chan V, Chen K, Ruel M, Chan K. Clinical evaluation of functional mitral stenosis after mitral valve repair for degenerative disease: potential affect on surgical strategy. J Thorac Cardiovasc Surg. 2013 Dec;146(6):1418-23; discussion 1423-5. doi: 10.1016/j.jtcvs.2013.08.011. Epub 2013 Sep 26.

    PMID: 24075470BACKGROUND

  • Gammie JS, Sheng S, Griffith BP, Peterson ED, Rankin JS, O'Brien SM, Brown JM. Trends in mitral valve surgery in the United States: results from the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg. 2009 May;87(5):1431-7; discussion 1437-9. doi: 10.1016/j.athoracsur.2009.01.064.

    PMID: 19379881BACKGROUND

  • Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.

    PMID: 16376782BACKGROUND

  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PMID: 12091180BACKGROUND

  • 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. 2025 Aug 7:S0022-5223(25)00654-3. doi: 10.1016/j.jtcvs.2025.07.047. Online ahead of print.

    PMID: 40783073DERIVED

  • 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.

    PMID: 36750353DERIVED

  • 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.

    PMID: 33017212DERIVED

  • 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.

    PMID: 28566364DERIVED

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve ProlapseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Vincent Chan, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

  • Subodh Verma, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Subodh Verma, MD

CONTACT

416-864-5997vermasu@smh.ca

David Mazer, MD

CONTACT

416-864-5825mazerd@smh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

September 17, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

December 7, 2018

Record last verified: 2018-12

Locations

CA(6)