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New study pokes at best fix for leaky heart valve in Blocked-Artery patients

NCT ID NCT04822675

Disease control Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two treatment options for people who have both a leaky heart valve (ischemic mitral regurgitation) and blocked heart arteries. One option is open-heart surgery to fix the valve and bypass the blockages at the same time. The other is a less invasive procedure to repair the valve, followed by surgery to bypass the blockages. The goal is to see which approach leads to better survival and fewer complications like heart attack or stroke. About 80 adults with severe valve leakage and reversible heart muscle damage will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Mitral valve insufficiency

Contacts and locations

Locations

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.