Recruiting

PFO Closure

Sponsor:

Josep Rodes-Cabau

Code:

NCT05907694

Conditions

Patent Foramen Ovale

Cryptogenic Stroke

Older Patients

Medical Treatment

Recurrent Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter PFO closure

Optimal medical treatment

Study Details

Brief summary:

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

Patent Foramen Ovale

Cryptogenic Stroke

Older Patients

Medical Treatment

Recurrent Stroke

Study ID

NCT05907694

Start date

Jun 18, 2024

Status verified date

Mar, 2026

Completion date

Oct 1, 2037

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

-≤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.
  • 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.

Study Design

Enrollment

714 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: transcatheter PFO closure + optimal medical treatment

Patients will undergoes transcatheter PFO closure (+ optimal medical treatment). Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

experimental: Optimal medical treatment

Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Interventions

Transcatheter PFO closure

Transcatheter PFO closure procedure will be performed according to the standards and experience of each participating center. Any approved PFO occluder device will be allowed in the study.

Patients will also receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Optimal medical treatment

Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Primary outcome measure

  • Rate of ischemic events [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Josep Rodes-Cabau, MD, PhD

4186568711josep.rodes@criucpq.ulaval.ca

Melanie Cote, MSc

4186568711melanie.cote@criucpq.ulaval.ca

Locations

IUCPQ

Recruiting

Québec, Quebec, Canada, G2E4G9

Contacts

Mélanie Côté

4186537270melanie.cote@criucpq.ulaval.ca

More Information

Sponsor

Josep Rodes-Cabau

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Josep Rodes-Cabau on 2026-03-27.