Mitral Valve InsufficiencyREVIVENCT04822675
REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial
A study testing Percutaneous mitral valve repair and Surgical mitral valve repair/replacement in people with Mitral Valve Insufficiency and Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Coronary Artery Disease
- What is being tested?
- Percutaneous mitral valve repair and Surgical mitral valve repair/replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 12 Aug 2021to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization
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.
- Being tested
- Percutaneous mitral valve repair, Surgical mitral valve repair/replacement
- Medical subject headings
- Mitral Valve Insufficiency, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous mitral valve repairProcedure or surgery
Percutaneous mitral repair will be performed using the MitraClip system.
Surgical mitral valve repair/replacementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous mitral repair | Experimental | Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair. Receives: Procedure: Percutaneous mitral valve repair |
| Mitral valve surgery | Active comparator | Surgical mitral valve surgery +/- coronary artery bypass grafting Receives: Procedure: Surgical mitral valve repair/replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
All-cause mortality. Death from cardiovascular and non-cardiovascular causes.
Measured: Within 12 months of intervention
Rate of myocardial infarction
These will be defined according to the Fourth Universal Definition of Myocardial Infarction
Measured: Within 12 months of intervention
Rate of Stroke
- 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.
Measured: 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%).
Measured: Within 12 months of intervention
Secondary outcomes (6)
Change in indexed left atrial volume
Measured: Within 6 and12 months of intervention
Degree of left ventricular remodeling
Quantified by the change in left ventricular end systolic volume index
Measured: Within 6 and12 months of intervention
Presence of recurrent MR ≥2+
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
Measured: Within 6 and12 months of intervention
Rate of mitral valve re-intervention
Measured: Within12 months of intervention
Number of Participants with worsening in heart failure symptoms
+1 NYHA Class
Measured: Within 6 and12 months of intervention
Cumulative hospital days
Measured: Within 12-months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start12 Aug 2021
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Chan, MD, MPH, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822675
- Sponsor's protocol ID
- 20210317
- Acronym
- REVIVE
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization
- ClinicalTrials.gov ID
- NCT04822675
- Acronym / sponsor ID
- REVIVE / 20210317
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Percutaneous mitral repair | Experimental | Procedure: Percutaneous mitral valve repairPercutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair. |
| Mitral valve surgery | Active comparator | Procedure: Surgical mitral valve repair/replacementSurgical mitral valve surgery +/- coronary artery bypass grafting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous mitral valve repairPercutaneous mitral repair will be performed using the MitraClip system. | Procedure or surgery | Percutaneous mitral repair |
| Surgical mitral valve repair/replacementAll 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. | Procedure or surgery | Mitral valve surgery |
Primary outcome
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%).
6 secondary outcomes
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
Presence of recurrent MR ≥2+
Time frame: Within 6 and12 months of intervention
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
Cumulative hospital days
Time frame: Within 12-months of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Chan, MD, MPH principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous mitral valve repair and Surgical mitral valve repair/replacement in people with Mitral Valve Insufficiency and Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: Within 12 months of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.