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Can closing a heart hole stop strokes in seniors? new trial aims to find out

NCT ID NCT05907694

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether closing a small hole in the heart (called a PFO) plus medication is better than medication alone at preventing repeat strokes in people over 60 who have had a cryptogenic stroke (a stroke with no clear cause). About 714 participants will be randomly assigned to either get the closure procedure or just medical treatment. The goal is to see if the procedure reduces the risk of another stroke in this older population, who have been left out of most previous studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcatheter PFO closure procedure plus antithrombotic medication
What this could lead to
If successful, this could provide an effective way to prevent recurrent strokes in older adults with a PFO, expanding treatment options beyond medication alone.
What could go wrong
This is an early-stage trial with no phase designation, and results may not confirm benefit. The procedure carries risks like bleeding, new atrial fibrillation, or device complications.

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 714 people

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

Started

Jun 2024

Expected to finish

Oct 2037

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: * Cryptogenic stroke * Age \>60 years * Right-to-left shunt as evaluated by echocardiography (TEE). Exclusion Criteria: -≤60 year-old * Lacunar (small vessel) stroke. * Permanent or paroxysmal atrial fibrillation/flutter (clinically apparent or detected by continuous ECG monitoring). * Need for chronic anticoagulation therapy. * Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor). * Presence of extracranial or intracranial atherosclerosis causing ≥50% luminal --stenosis in arteries supplying the area of ischemia. * Presence of complex atheroma plaques at the ascending aorta-aortic arch (≥4-mm-thick, ulcerated or containing mobile thrombi) as evaluated by TEE. * Presence of intracardiac thrombus as evaluated by TEE. * Uncontrolled hypertension (systemic pressure values \>160/90 mmHg despite optimal medical treatment). * History of myocardial infarction or coronary intervention. (percutaneous coronary intervention, coronary artery bypass graft). * History of prior valve surgery or transcatheter valve repair. * Presence of deep venous thrombosis at the time of index stroke as evaluated by Doppler ultrasonography. * Left ventricular ejection fraction \<50% as evaluated by TTE. * Significant (moderate or severe) valvular disease as evaluated by echocardiography. * History of congestive heart failure. * Severe chronic kidney dysfunction defined an estimated glomerular filtration rate \<30 ml/min/m2 or need for dialysis. * Isolated ASD or ASD associated with PFO but with a hemodynamically significant left-to-right shunt requiring closure. * Other specific cause of stroke identified (eg, arteritis, dissection, migraine/vasospasm, and drug abuse). * Prior surgical or endovascular treatments of PFO or ASD. * Rheumatic heart disease. * Left atrial enlargement defined as a left atrial diameter \>41 mm in men and ≥39 mm in women. * Presence of high burden of premature atrial contractions (\>500 per 24 hrs) as evaluated by continuous ECG monitoring. * Follow-up impossible or expected poor compliance. * Active cancer. * Presence of an inferior vena cava filter. * Severe pulmonary artery hypertension (systolic pulmonary pressure \>60 mmHg). * Functional dependency as measured by a modified Rankin Scale score \>3 (unable to attend to own bodily needs without assistance and unable to walk unassisted). * Any medical condition determining a life expectancy \<2 years. * Participation in another randomized study. * Failure to provide signed informed consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IUCPQ

    RECRUITING

    Québec, Quebec, G2E4G9, Canada

  • IUCPQ-UL

    ACTIVE_NOT_RECRUITING

    Québec, Quebec, G1V 4G5, Canada

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