REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Mar 25, 2021

Keywords

ClinConnect Summary

The REVIVE Trial is studying two different ways to treat a condition called ischemic mitral regurgitation (MR), which is when the heart's mitral valve doesn't close properly, often due to coronary artery disease. This trial aims to find out whether patients do better with traditional surgery to repair or replace the valve, along with bypass surgery to improve blood flow to the heart, or with a newer, less invasive procedure called percutaneous mitral repair, followed by the same bypass surgery.

To join the trial, participants need to be between 65 and 74 years old and have severe ischemic MR confirmed by an ultrasound of the heart. They also must have a specific type of heart issue that can be improved with treatment. However, people with certain heart conditions or those who have had previous valve repairs won't be eligible. If you participate, you'll be randomly assigned to one of the two treatment options, and the trial will help researchers understand which method might be better for patients with this condition. This study is currently recruiting participants and aims to provide valuable insights into heart care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging.
• Exclusion Criteria:
• • 1. Patients with mixed mitral valve pathology, including fibroelastic deficiency, rheumatic valve disease, ruptured mitral valve chordae, mitral valve endocarditis.
• • 2. Patients with acute ischemic MR, defined as MR caused by papillary muscle infarction and rupture.
• • 3. Age \< 18 years.
• • 4. Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) as defined by the Heart Team.
• • 5. Need for a concomitant surgical procedure, excluding Coronary artery bypass grafting (CABG), tricuspid valve repair, Patent foramen ovale (PFO) closure, Atrial septal defect (ASD) closure and Maze procedure.
• • 6. Prior mitral valve repair procedure (percutaneous or surgical).
• • 7. Leaflet anatomy unsuitable for MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip.