REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial (NCT04822675)
A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Ottawa Heart Institute โ Ottawa, Ontario
Age range: 18 Years
๐งช Interventions in This Study
- Percutaneous mitral valve repair (PROCEDURE)
- Surgical mitral valve repair/replacement (PROCEDURE)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- University of Ottawa Heart Institute โ Ottawa, Ontario
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Mitral Valve Insufficiency
- Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair โ Sacramento, California
- Long Term Follow Up for CTSN Mitral Valve Repair Studies โ Los Angeles, California
- PARTNER 3 Trial - Mitral Valve in Valve โ Atlanta, Georgia
- Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System โ Phoenix, Arizona
- The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study โ New York, New York
Explore by condition: All Mitral Valve Insufficiency clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.