International PFO Consortium

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke). Given the large number of asymptomatic patients, no primary prevention is currently recommended. On the contrary, secondary prevention is very important. Prospective studies have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the risk of recurrent stroke associated with a PFO. Patients with spontaneous or large right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple ischemic events prior to the PFO diagnosis may still be at increased risk of stroke recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates. The aim of the present study is to compare the risk of recurrent stroke and TIA in patients with PFO and otherwise unexplained stroke who undergo PDC or receive ATT.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Alfried-Krupp Krankenhaus of Essen, Germany; Ammerland Klinik GmbH, Westerstede, Germany; Arcispedale Santa Maria Nuova-IRCCS; Baystate Medical Center; Cantonal Hospital of Aarau, Switzerland; East Medical Center Tyler, Texas; Klinikum Worms; Triemli Hospital; Tufts Medical Center; Universitaire Ziekenhuizen Leuven; University Hospital, Basel, Switzerland; University Hospital, Essen; University Hospital, Geneva; University Hospital, Ghent; University Hospital, Zürich; University of Lausanne Hospitals
• Treatments: Aspirin; Clopidogrel

Criteria

Inclusion Criteria:

• Age > 18 years

• Diagnosis of PFO established by transesophageal echocardiography (TEE)

• Ischemic stroke or transient ischemic attack within the previous 6 months

Exclusion Criteria

• Non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI)

• Comorbid condition that would interfere with the study

• Pregnancy

• History of intracranial bleeding, confirmed arterio-venous malformation, aneurysm or uncontrolled coagulopathy

• Contraindications for TEE, echocardiographic or iodine contrast media