Recruiting

CardioLink-2

Sponsor:

Unity Health Toronto

Code:

NCT02552771

Conditions

Mitral Valve Prolapse

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Mitral repair with leaflet preservation

Mitral repair with leaflet resection

Study Details

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.

Conditions

Mitral Valve Prolapse

Study ID

NCT02552771

Start date

Jan, 2016

Status verified date

Dec, 2018

Completion date

Jan, 2020

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

active comparator: Mitral repair with leaflet resection

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

Interventions

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).

Mitral repair with leaflet resection

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Subodh Verma, MD

416-864-5997vermasu@smh.ca

David Mazer, MD

416-864-5825mazerd@smh.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Vincent Chan, MD

613-798-5555VChan@ottawaheart.ca

Jacqueline Fortier, Msc

613-798-5555JFortier@ottawaheart.ca

Principal Investigator:

Vincent Chan, MD

St Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Subodh Verma, MD

(416) 864-5997vermasu@smh.ca

Sanjay Yagnik

416-864-6060YagnikS@smh.ca

Principal Investigator:

Subodh Verma, MD

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Benoit de Varennes, MD

514-934-1934benoit.devarennes@muhc.mcgill.ca

Carole Albert

514-934-1934carole.albert@muhc.mcgill.ca

Principal Investigator:

Benoit de Varennes, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Dec 7, 2018

Last verified

Dec, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2018-12-07.