Transcatheter closure versus medical therapy for PFO in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial will enroll patients older than 60 who had a recent cryptogenic nonlacunar ischemic stroke and a PFO confirmed by transesophageal echocardiography with right-to-left shunt. Participants are randomized to transcatheter PFO closure plus optimal medical therapy or to optimal medical therapy alone, with follow-up for recurrent ischemic stroke events. Key exclusions include lacunar stroke, atrial fibrillation, need for chronic anticoagulation, significant extracranial or intracranial atherosclerosis, intracardiac thrombus, and uncontrolled hypertension. The primary outcome is prevention of recurrent nonlacunar ischemic stroke, with mid- to long-term follow-up to capture recurrence rates and safety events.

Why it matters

Who can join: the full rules

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.

Where it's running

• Iucpq
  Québec, Quebec, Canada Recruiting
• Iucpq-Ul
  Québec, Quebec, Canada Active not recruiting

Study contacts

• Principal investigator: IUCPQ Rodes-Cabau, MD, PhD — Fondation IUCPQ
• Study coordinator: Josep Rodes-Cabau, MD, PhD
• Email: josep.rodes@criucpq.ulaval.ca
• Phone: 4186568711

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.