Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

Recruiting now · Not applicable

Conditions studied: Patent Foramen Ovale, Cryptogenic Stroke, Older Patients, Medical Treatment, Recurrent Stroke

In brief

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.

Key facts

Study ID

NCT05907694

Run by

Josep Rodes-Cabau

People needed

714

Starts

2024-06-18

Expected to finish

2037-10-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cryptogenic stroke
• Age >60 years
• Right-to-left shunt as evaluated by echocardiography (TEE).

You may not qualify if…

• ≤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.

Where it is running

• IUCPQ — Québec, Quebec, Canada (enrolling)
• IUCPQ-UL — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.