International PFO Consortium

NCT00859885 | Unknown

• 1 other identifier: 117/08
• Study Type: observational
• Target: 1,500
• Locations: 6 countries
• Sites: 18

Brief 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

Keywords

patent foramen ovale; ischemic stroke; transient ischemic attack; secondary prevention; medical treatment; percutaneous device closure

Outcome Measures

Primary Outcomes (1)

• proportion of patients free of any stroke (including fatal stroke) or TIA

  3 years

Secondary Outcomes (3)

• influence of gender, age, spontaneous or large shunt, coincidence of an atrial septum aneurysma

  3 years

• influence of competitive causes of stroke

  3 years

• frequency of residual shunt, (in)correct device position, need for implantation of second device and periprocedural complications

  30 days and 6 months

Study Arms (2)

1

Patients who receive antithrombotic treatment only

Drug: Antithrombotic treatment

2

Patients who undergo percutaneous device closure

Device: percutaneous device closure of PFO

Interventions

Antithrombotic treatment DRUG

antiplatelets, anticoagulants

Also known as: aspirin

1

percutaneous device closure of PFO DEVICE

umbrella device for PFO closure

Also known as: clopidogrel

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic stroke or transient ischemic attacks, in whom a patent foramen ovale has been diagnosed by means of a transesophageal echocardiography

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital, Basel, Switzerland: collaborator
• University of Lausanne Hospitals: collaborator
• University Hospital, Geneva: collaborator
• University Hospital, Zürich: collaborator
• Triemli Hospital: collaborator
• Cantonal Hospital of Aarau, Switzerland: collaborator
• Alfried-Krupp Krankenhaus of Essen, Germany: collaborator
• University Hospital, Essen: collaborator
• Klinikum Worms: collaborator
• Tufts Medical Center: collaborator
• Baystate Medical Center: collaborator
• East Medical Center Tyler, Texas: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Ammerland Klinik GmbH, Westerstede, Germany: collaborator
• University Hospital, Ghent: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator

Study Sites (18)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

COMPLETED

East Medical Center

Tyler, Texas, 75710, United States

RECRUITING

University Hospital Gent

Ghent, 9000, Belgium

RECRUITING

Leuven University Hospital

Leuven, 3000, Belgium

RECRUITING

Alfried Krupp Hospital

Essen, 45117, Germany

RECRUITING

Essen University Hospital

Essen, 45147, Germany

RECRUITING

Ammerland Klinik GmbH

Westerstede, 26655, Germany

RECRUITING

Klinikum Worms gGmbH

Worms, 67550, Germany

RECRUITING

Arcispedale Santa Maria Nuova, Department of Neurology, ASMN IRCCS

Reggio Emilia, 42123, Italy

RECRUITING

University Hospital Doctor Josep Trueta

Girona, 17707, Spain

RECRUITING

Cantonal Hospital of Aarau

Aarau, 5001, Switzerland

RECRUITING

Basel University Hospital

Basel, 4031, Switzerland

COMPLETED

Department of Neurology, Bern University Hospital, Bern

Bern, 3010, Switzerland

RECRUITING

Geneva University Hospital

Geneva, 1211, Switzerland

RECRUITING

Lausanne University Hospital

Lausanne, 1011, Switzerland

RECRUITING

Zürich Triemli Hospital

Zurich, 8063, Switzerland

COMPLETED

Zürich University Hospital

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Foramen Ovale, Patent; Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Krassen Nedeltchev, MD

  Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

• Marie-Luise Mono, MD

  Dep. of Neurology, Bern University Hospital, Bern

  PRINCIPAL INVESTIGATOR

• Marcel Arnold, MD

  University of Bern, Inselspital

  STUDY DIRECTOR

Central Study Contacts

Krassen Nedeltchev, MD

CONTACT

+41 62 838 66 75; Krassen.Nedeltchev@ksa.ch

Marie-Luise Mono, MD

CONTACT

+41316320743; marie-luise.mono@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 11, 2009
• Study Start: September 8, 2008
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

ES (1); CH (7); DE (4); IT (1); BE (2); US (3)