REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Mitral Valve Insufficiency
• Interventions: Procedure: Surgical mitral valve repair/replacement; Procedure: Percutaneous mitral valve repair

• Registration Number: NCT04822675
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-30
• Study Start: 2021-08-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitral valve surgery	Surgical mitral valve repair/replacement	Surgical mitral valve surgery +/- coronary artery bypass grafting
Percutaneous mitral repair	Percutaneous mitral valve repair	Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.

Primary Outcome Measures

Name	Time	Method
Hospitalization rate for congestive heart failure	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%).
Rate of myocardial infarction	Within 12 months of intervention	These will be defined according to the Fourth Universal Definition of Myocardial Infarction
Mortality rate	Within 12 months of intervention	All-cause mortality. Death from cardiovascular and non-cardiovascular causes.
Rate of Stroke	Within 12 months of intervention	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.

Secondary Outcome Measures

Name	Time	Method
Presence of recurrent MR ≥2+	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
Change in indexed left atrial volume	Within 6 and12 months of intervention
Rate of mitral valve re-intervention	Within12 months of intervention
Degree of left ventricular remodeling	Within 6 and12 months of intervention	Quantified by the change in left ventricular end systolic volume index
Cumulative hospital days	Within 12-months of intervention
Number of Participants with worsening in heart failure symptoms	Within 6 and12 months of intervention	+1 NYHA Class

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada