International PFO Consortium

Status unconfirmed

Conditions studied: Stroke, Transient Ischemic Attack

In brief

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.

Key facts

Study ID

NCT00859885

Run by

Insel Gruppe AG, University Hospital Bern

People needed

1500

Starts

2008-09-08

Expected to finish

2021-12-01

Last updated by the study team

2017-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Diagnosis of PFO established by transesophageal echocardiography (TEE)
• Ischemic stroke or transient ischemic attack within the previous 6 months

You may not qualify if…

• 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

Where it is running

• Zürich University Hospital — Zurich, Switzerland (enrolling)
• Geneva University Hospital — Geneva, Switzerland (enrolling)
• Lausanne University Hospital — Lausanne, Switzerland (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• East Medical Center — Tyler, Texas, United States (enrolling)
• University Hospital Gent — Ghent, Belgium (enrolling)
• Leuven University Hospital — Leuven, Belgium (enrolling)
• Alfried Krupp Hospital — Essen, Germany (enrolling)
• Essen University Hospital — Essen, Germany (enrolling)
• Ammerland Klinik GmbH — Westerstede, Germany (enrolling)
• Klinikum Worms gGmbH — Worms, Germany (enrolling)
• Arcispedale Santa Maria Nuova, Department of Neurology, ASMN IRCCS — Reggio Emilia, Italy (enrolling)
• University Hospital Doctor Josep Trueta — Girona, Spain (enrolling)
• Cantonal Hospital of Aarau — Aarau, Switzerland (enrolling)
• Department of Neurology, Bern University Hospital, Bern — Bern, Switzerland (enrolling)
• Baystate Medical Center — Springfield, Massachusetts, United States
• Basel University Hospital — Basel, Switzerland
• Zürich Triemli Hospital — Zurich, Switzerland

Full record on ClinicalTrials.gov

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