Clinical trial NCT04822675: REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial
Official title: A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Insufficiency
Coronary Artery Disease
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mortality rate
timeFrame: Within 12 months of intervention
measure: Rate of myocardial infarction
timeFrame: Within 12 months of intervention
measure: Rate of Stroke
timeFrame: Within 12 months of intervention
measure: Hospitalization rate for congestive heart failure
timeFrame: Within 12 months of intervention
Secondary outcomes:
measure: Change in indexed left atrial volume
timeFrame: Within 6 and12 months of intervention
measure: Degree of left ventricular remodeling
timeFrame: Within 6 and12 months of intervention
measure: Presence of recurrent MR ≥2+
timeFrame: Within 6 and12 months of intervention
measure: Rate of mitral valve re-intervention
timeFrame: Within12 months of intervention
measure: Number of Participants with worsening in heart failure symptoms
timeFrame: Within 6 and12 months of intervention
measure: Cumulative hospital days
timeFrame: Within 12-months of intervention
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Vincent Chan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: