Can closing a heart hole stop strokes in seniors? new trial aims to find out
NCT ID NCT05907694
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
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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
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About 714 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Oct 2037
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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IUCPQ
RECRUITINGQuébec, Quebec, G2E4G9, Canada
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IUCPQ-UL
ACTIVE_NOT_RECRUITINGQuébec, Quebec, G1V 4G5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Can a common heart drug stop rhythm problems after a Stroke-Related heart repair?
- Could a Drug-Coated balloon beat stents for a common heart attack cause?
- Artery plaque scans may reveal hidden stroke risk
- Can closing a hole in the heart prevent future strokes? a long-term study seeks answers.
- Brain artery stent coated with drug may cut stroke risk better than pills alone