REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

NCT ID: NCT04822675

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-12
• Study Completion Date: 2026-08-31

Brief 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.

Conditions

Mitral Valve Insufficiency; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous mitral repair

Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.

Group Type: EXPERIMENTAL

Percutaneous mitral valve repair

Intervention Type: PROCEDURE

Percutaneous mitral repair will be performed using the MitraClip system.

Mitral valve surgery

Surgical mitral valve surgery +/- coronary artery bypass grafting

Group Type: ACTIVE_COMPARATOR

Surgical mitral valve repair/replacement

Intervention Type: PROCEDURE

All mitral valve surgeries will be performed either via sternotomy or right thoracotomy, and with cardioplegic arrest and cardiopulmonary bypass. Mitral valve repair may include annuloplasty and adjunctive procedures as determined by the operating surgeon. For mitral valve replacement, the choice of mitral valve prosthesis will be left at the surgeon's discretion.

Interventions

Percutaneous mitral valve repair

Percutaneous mitral repair will be performed using the MitraClip system.

Intervention Type: PROCEDURE

Surgical mitral valve repair/replacement

All mitral valve surgeries will be performed either via sternotomy or right thoracotomy, and with cardioplegic arrest and cardiopulmonary bypass. Mitral valve repair may include annuloplasty and adjunctive procedures as determined by the operating surgeon. For mitral valve replacement, the choice of mitral valve prosthesis will be left at the surgeon's discretion.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Chan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mary Zhang, MD, PhD

Role: CONTACT

mzhang@ottawaheart.ca

613-696-7230

Facility Contacts

Mary Zhang, MD, PhD

Role: primary

mzhang@ottawaheart.ca

613-696-7230

Other Identifiers

20210317

Identifier Type: -

Identifier Source: org_study_id