International PFO Consortium

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.

Conditions

• Stroke
• Transient Ischemic Attack

Interventions

DRUG

Antithrombotic treatment

antiplatelets, anticoagulants

DEVICE

percutaneous device closure of PFO

umbrella device for PFO closure

Sponsors & Collaborators

• University Hospital, Basel, Switzerland

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• University Hospital, Zürich

  collaborator OTHER

• Triemli Hospital

  collaborator OTHER

• Cantonal Hospital of Aarau, Switzerland

  collaborator OTHER

• Alfried-Krupp Krankenhaus of Essen, Germany

  collaborator UNKNOWN

• University Hospital, Essen

  collaborator OTHER

• Klinikum Worms

  collaborator OTHER

• Tufts Medical Center

  collaborator OTHER

• Baystate Medical Center

  collaborator OTHER

• East Medical Center Tyler, Texas

  collaborator UNKNOWN

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Ammerland Klinik GmbH, Westerstede, Germany

  collaborator UNKNOWN

• University Hospital, Ghent

  collaborator OTHER

• Azienda USL Reggio Emilia - IRCCS

  collaborator OTHER_GOV

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Krassen Nedeltchev, MD · Kantonsspital Aarau

• Marie-Luise Mono, MD · Dep. of Neurology, Bern University Hospital, Bern

• Marcel Arnold, MD · University of Bern, Inselspital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-08

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• United States
• Belgium
• Germany
• Italy
• Spain
• Switzerland

Study Locations