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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Coronary Artery Disease Procedure: Percutaneous mitral valve repair Procedure: Surgical mitral valve repair/replacement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 : August 2025
Estimated Study Completion Date : August 2026

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MedlinePlus related topics: Caffeine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 ]
    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.

  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Mary Zhang, MD, PhD 613-696-7230 mzhang@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Mary Zhang, MD, PhD    613-696-7230    mzhang@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Vincent Chan, MD, MPH Ottawa Heart Institute Research Corporation
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT04822675    
Other Study ID Numbers: 20210317
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: January 10, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Mitral Valve Insufficiency
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases