Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

Trial details

Who runs it

Josep Rodes-Cabau

Trial code

NCT05907694

Record updated

27 March 2026

Original description

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.Read full original descriptionShow less

Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial

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.

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

Exclusion: Need for chronic anticoagulation therapy; Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor); History of prior valve surgery or transcatheter valve repair; Prior surgical or endovascular treatments of PFO or ASD; Lacunar (small vessel) stroke; 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); Presence of deep venous thrombosis at the time of index stroke as evaluated by Doppler ultrasonography; Significant (moderate or severe) valvular disease as evaluated by echocardiography; History of congestive heart failure; Other specific cause of stroke identified (eg, arteritis, dissection, migraine/vasospasm, and drug abuse); Rheumatic heart disease; Active cancer; Severe pulmonary artery hypertension (systolic pulmonary pressure >60 mmHg); Failure to provide signed informed consent; Left ventricular ejection fraction <50% as evaluated by TTE; Any medical condition determining a life expectancy <2 years; -≤60 year-old; Permanent or paroxysmal atrial fibrillation/flutter (clinically apparent or detected by continuous ECG monitoring); 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; 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; 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; Presence of an inferior vena cava filter; 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); Participation in another randomized study.

ClinicalTrials.gov NCT05907694