Coronary Artery Disease Clinical Trial
Official title:
A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair and Revascularization Either Percutaneously or Through a Hybrid Approach
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 the ideal Heart Team determined mode of revascularization with either percutaneous coronary intervention or coronary artery bypass grafting.
n/a
| NCT number | NCT04822675 |
| Study type | Interventional |
| Source | Ottawa Heart Institute Research Corporation |
| Contact | Mary Zhang, MD, PhD |
| Phone | 613-696-7230 |
| [email protected] | |
| Status | Not yet recruiting |
| Phase | N/A |
| Start date | June 2021 |
| Completion date | June 2025 |
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