A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Ischemic mitral regurgitation (MR) and coronary artery disease is common and associated with significant morbidity and mortality. Ischemic MR has been traditionally treated surgically through either valve repair or replacement at the time of concomitant bypass grafting. Although patients with ischemic MR represent a heterogeneous group, outcomes for these patients over the intermediate term is poor owing to left ventricle (LV) dysfunction causing MR and the presence of coronary disease, which portends poor survival. There is an emergence of percutaneous therapies to treat MR which have been shown to be a less invasive, safe, and viable approach to treat comorbid patients. The decision to treat ischemic MR either surgically or percutaneously is influenced by the presence of coronary disease and the ability to provide adequate revascularization. Mitral valve surgery concomitant to surgical revascularization, however, is associated with a several fold increase in mortality. In fact, the incremental risk increase is further magnified in high-risk patients. We therefore propose a novel prospective study to guide intervention for ischemic MR. Patients will be randomized to undergo surgical therapy with either mitral repair/replacement and/or concomitant coronary artery bypass grafting OR percutaneous mitral repair, followed by coronary artery bypass grafting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with severe ischemic Mitral regurgitation (MR), as defined by the 2017 American Society of Echocardiography (ASE) guidelines for noninvasive evaluation of native valvular regurgitation.

• Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging.

Locations
Other Locations
Canada
University of Ottawa Heart Institute
RECRUITING
Ottawa
Contact Information
Primary
Mary Zhang, MD, PhD
mzhang@ottawaheart.ca
613-696-7230
Time Frame
Start Date: 2021-08-12
Estimated Completion Date: 2026-08
Participants
Target number of participants: 80
Treatments
Experimental: Percutaneous mitral repair
Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.
Active_comparator: Mitral valve surgery
Surgical mitral valve surgery +/- coronary artery bypass grafting
Sponsors
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov