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NCT Number: NCT04822675

REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

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.

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Key information

Conditions

Mitral Valve Insufficiency Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Percutaneous mitral valve repair

Procedure

Percutaneous mitral repair will be performed using the MitraClip system.

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.

Primary outcomes

  1. Mortality rate

    Time frame: Within 12 months of intervention

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

  2. Rate of myocardial infarction

    Time frame: Within 12 months of intervention

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

  3. Rate of Stroke

    Time frame: Within 12 months of intervention

    • 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.

  4. Hospitalization rate for congestive heart failure

    Time frame: Within 12 months of intervention

    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%).

Secondary outcomes

  1. Change in indexed left atrial volume

    Time frame: Within 6 and12 months of intervention

  2. Degree of left ventricular remodeling

    Time frame: Within 6 and12 months of intervention

    Quantified by the change in left ventricular end systolic volume index

  3. Presence of recurrent MR ≥2+

    Time frame: Within 6 and12 months of intervention

    Defined as a regurgitant volume of 30-44 ml, a right ventricular ejection fraction of 30-39%, or an effective regurgitant orifice area of 20-29 mm2

  4. Rate of mitral valve re-intervention

    Time frame: Within12 months of intervention

  5. Number of Participants with worsening in heart failure symptoms

    Time frame: Within 6 and12 months of intervention

    +1 NYHA Class

  6. Cumulative hospital days

    Time frame: Within 12-months of intervention

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization

Acronym: REVIVE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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