REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

NCT04822675 | Active Not Recruiting DMC

• 1 other identifier: 20210317
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Mortality rate

  All-cause mortality. Death from cardiovascular and non-cardiovascular causes.

  Within 12 months of intervention

• Rate of myocardial infarction

  These will be defined according to the Fourth Universal Definition of Myocardial Infarction

  Within 12 months of intervention

• Rate of Stroke

  1\) New, acute focal neurological deficit thought to be of vascular origin with signs or symptoms lasting \> 24 h and confirmed by a neurologist or 2) new, focal neurological deficit lasting \> 24 h with imaging evidence of cerebral infarction or intracerebral hemorrhage.

  Within 12 months of intervention

• Hospitalization rate for congestive heart failure

  Admission to hospital with congestive heart failure exacerbation being the primary reason for admission. Congestive heart failure exacerbation is defined as 1) evidence of fluid overload and elevated filling pressures (for example, a central venous pressure \> 8mmHg and/or a pulmonary capillary wedge pressure \> 18mmHg) and/or 2) new decrease in cardiac output (for example, cardiac index \< 2.2 L/min/m2) and end-organ perfusion (measured by one or more of: urine output \< 20mL/hr, lactate \>= 2.0, mixed venous oxygen saturation \< 70%).

  Within 12 months of intervention

Secondary Outcomes (6)

• Change in indexed left atrial volume

  Within 6 and12 months of intervention

• Degree of left ventricular remodeling

  Within 6 and12 months of intervention

• Presence of recurrent MR ≥2+

  Within 6 and12 months of intervention

• Rate of mitral valve re-intervention

  Within12 months of intervention

• Number of Participants with worsening in heart failure symptoms

  Within 6 and12 months of intervention

Study Arms (2)

Percutaneous mitral repair

EXPERIMENTAL

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

Procedure: Percutaneous mitral valve repair

Mitral valve surgery

ACTIVE COMPARATOR

Surgical mitral valve surgery +/- coronary artery bypass grafting

Procedure: Surgical mitral valve repair/replacement

Interventions

Percutaneous mitral valve repair PROCEDURE

Percutaneous mitral repair will be performed using the MitraClip system.

Percutaneous mitral repair

Surgical mitral valve repair/replacement 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.

Mitral valve surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging.

You may not qualify if:

• Patients with mixed mitral valve pathology, including fibroelastic deficiency, rheumatic valve disease, ruptured mitral valve chordae, mitral valve endocarditis.
• Patients with acute ischemic MR, defined as MR caused by papillary muscle infarction and rupture.
• Age \< 18 years.
• Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) as defined by the Heart Team.
• 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.
• Prior mitral valve repair procedure (percutaneous or surgical).
• Leaflet anatomy unsuitable for MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Coronary Artery Disease

Interventions

Replantation

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Vincent Chan, MD, MPH

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized trial

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 30, 2021
• Study Start: August 12, 2021
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)