REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial (REVIVE)
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|ClinicalTrials.gov Identifier: NCT04822675
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : January 10, 2024
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.
|Condition or disease
|Mitral Valve Insufficiency Coronary Artery Disease
|Procedure: Percutaneous mitral valve repair Procedure: Surgical mitral valve repair/replacement
|Study Type :
|Interventional (Clinical Trial)
|Estimated Enrollment :
|Intervention Model Description:
|Prospective randomized trial
|None (Open Label)
|A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization
|Actual Study Start Date :
|August 12, 2021
|Estimated Primary Completion Date :
|Estimated Study Completion Date :
Experimental: Percutaneous mitral repair
Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.
Procedure: Percutaneous mitral valve repair
Percutaneous mitral repair will be performed using the MitraClip system.
Active Comparator: Mitral valve surgery
Surgical mitral valve surgery +/- coronary artery bypass grafting
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.
- Mortality rate [ Time Frame: Within 12 months of intervention ]All-cause mortality. Death from cardiovascular and non-cardiovascular causes.
- Rate of myocardial infarction [ Time Frame: Within 12 months of intervention ]These will be defined according to the Fourth Universal Definition of Myocardial Infarction
- Rate of Stroke [ Time Frame: 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.
- 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%).
- Change in indexed left atrial volume [ Time Frame: Within 6 and12 months of intervention ]
- Degree of left ventricular remodeling [ Time Frame: Within 6 and12 months of intervention ]Quantified by the change in left ventricular end systolic volume index
- 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
- Rate of mitral valve re-intervention [ Time Frame: Within12 months of intervention ]
- Number of Participants with worsening in heart failure symptoms [ Time Frame: Within 6 and12 months of intervention ]+1 NYHA Class
- Cumulative hospital days [ Time Frame: Within 12-months of intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822675
|Contact: Mary Zhang, MD, PhD
|University of Ottawa Heart Institute
|Ottawa, Ontario, Canada, K1Y 4W7
|Contact: Mary Zhang, MD, PhD 613-696-7230 firstname.lastname@example.org
|Vincent Chan, MD, MPH
|Ottawa Heart Institute Research Corporation