Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJosep Rodes-Cabau

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

714 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Josep Rodes-Cabau

Lead sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Sponsor institution