Actively Recruiting
Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
Led by Josep Rodes-Cabau · Updated on 2026-03-27
714
Participants Needed
2
Research Sites
693 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cryptogenic stroke
- Age >60 years
- Right-to-left shunt as evaluated by echocardiography (TEE).
You will not qualify if you...
- Age ≤60 years
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
IUCPQ-UL
Québec, Quebec, Canada, G1V 4G5
Active, Not Recruiting
2
IUCPQ
Québec, Quebec, Canada, G2E4G9
Actively Recruiting
Research Team
J
Josep Rodes-Cabau, MD, PhD
CONTACT
M
Melanie Cote, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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