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Clinical Trials in Canada / NCT05907694
Recruiting Not applicable

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

NCT05907694 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2024-06-18
Last updated
2026-03-27

Condition(s) studied

Patent Foramen OvaleCryptogenic StrokeOlder PatientsMedical TreatmentRecurrent Stroke

Investigational drug(s) / intervention(s)

Transcatheter PFO closureOptimal medical treatment

Transcatheter PFO closure: Transcatheter PFO closure procedure will be performed according to the standards and experience of each participating center. Any approved PFO occluder device will be allowed in the study. Patients will also receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Optimal medical treatment: Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Study summary

Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
IUCPQ-UL Québec Quebec Active Not Recruiting
IUCPQ Québec Quebec Recruiting

More Josep Rodes-Cabau trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05907694 on ClinicalTrials.gov ↗ ← All trials in Canada