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

NCT02552771 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2018-12-07

No results posted yet for this study

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

Interventions

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).

PROCEDURE

Mitral repair with leaflet resection

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

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Vincent Chan, MD · Ottawa Heart Institute Research Corporation

  • Subodh Verma, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-01-31
Completion
2020-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02552771 on ClinicalTrials.gov