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Trial record 58 of 245 for:    "ottawa heart institute"

Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

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ClinicalTrials.gov Identifier: NCT03292497
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking, as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve. Currently, we don't have very strong evidence showing which patients might benefit from mitral valve repair and which might benefit from replacement, and surgeons tend to repair or replace valves based on their preference or experience. Some surgeons, including Dr. Vincent Chan, the Principal Investigator, believe that the decision to repair or replace the valve should be based on specific measurements of the mitral valve. This study will randomly assign patients to receive either the current standard of care for ischemic mitral regurgitation, which is valve repair or replacement based on the surgeon's preference, or to have their treatment decided by a set of criteria called an algorithm. This algorithm will assign patients with certain mitral valve measurements to repair, and others to replacement. Patients will be followed for 12 months after surgery, to compare whether patients whose treatment was decided by the algorithm did better than patients whose treatment was decided by surgeon preference.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Procedure: Treatment Algorithm Procedure: No Treatment Algorithm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Echocardiographic outcome assessment will be blinded.
Primary Purpose: Treatment
Official Title: Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation: Canadian Mitral Research Alliance (CAMRA) 2 Trial
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Treatment algorithm

Mitral valve will be replaced if posterior leaflet tethering angle >=25 degrees.

Mitral valve will be repaired if posterior leaflet tethering angle <25 degrees

Procedure: Treatment Algorithm
Patients will have their procedure dictated by a treatment algorithm. They will have their mitral valve replaced if the posterior leaflet tethering angle >=25 degrees, or repaired if the posterior leaflet tethering angle <25 degrees.

Active Comparator: No treatment algorithm
Mitral valve will be repaired or replaced at surgeon's discretion.
Procedure: No Treatment Algorithm
Patients will have their valve repaired or replaced at the discretion of their surgeon.




Primary Outcome Measures :
  1. Left ventricle end-systolic volume indexed to body surface area [ Time Frame: 12 months after surgery ]
    Comparison of changes in the indexed volume of the left ventricle.


Secondary Outcome Measures :
  1. Change in indexed left atrial volume [ Time Frame: Up to 12 months after surgery ]
    Comparison of changes in the indexed volume of the left atrium.

  2. Change in right ventricle systolic pressure [ Time Frame: Up to 12 months after surgery ]
    Comparison of changes in the systolic pressure of the right ventricle.

  3. Major adverse events [ Time Frame: Up to 12 months after surgery ]
    Composite endpoint of survival, recurrence of clinically-significant (>= 2+) mitral regurgitation, and readmission to hospital for congestive heart failure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe ischemic mitral valve regurgitation

    • 18 years of age, and able to provide informed consent.

Exclusion Criteria:

  • Mixed mitral valve pathology
  • Acute ischemic mitral regurgitation

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): NCT03292497


Contacts
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Contact: Vincent Chan, MD 613-696-7294 vchan@ottawaheart.ca
Contact: Jacqueline Fortier 613-696-7000 ext 18329 jfortier@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Vincent Chan    613-696-7294    vchan@ottawaheart.ca   
Contact: Jacqueline Fortier    613-696-7000 ext 18329    jfortier@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Vincent Chan, MD Ottawa Heart Institute Research Corporation

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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03292497     History of Changes
Other Study ID Numbers: 20170700
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases