About this 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.
Eligibility criteria
Qualifiers
Cryptogenic stroke
Age >60 years
Right-to-left shunt as evaluated by echocardiography (TEE).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Transcatheter PFO closure
- Optimal medical treatment
Treatment groups
Sponsors and collaborators
Josep Rodes-Cabau
Lead sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor institution