International PFO Consortium

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
University Hospital, Geneva
University Hospital, Zürich
Triemli Hospital
Cantonal Hospital of Aarau, Switzerland
Alfried-Krupp Krankenhaus of Essen, Germany
University Hospital, Essen
Klinikum Worms gGmbH, Germany
Tufts Medical Center
Baystate Medical Center
East Medical Center Tyler, Texas
Universitaire Ziekenhuizen Leuven
Ammerland Klinik GmbH, Westerstede, Germany
University Hospital, Ghent
Arcispedale Santa Maria Nuova-IRCCS
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00859885
First received: March 6, 2009
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Stroke
Transient Ischemic Attack
Drug: Antithrombotic treatment
Device: percutaneous device closure of PFO

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Secondary Stroke Prevention In Patients With Patent Foramen Ovale: International PFO Consortium

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • proportion of patients free of any stroke (including fatal stroke) or TIA [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • influence of gender, age, spontaneous or large shunt, coincidence of an atrial septum aneurysma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • influence of competitive causes of stroke [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • frequency of residual shunt, (in)correct device position, need for implantation of second device and periprocedural complications [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients who receive antithrombotic treatment only
Drug: Antithrombotic treatment
antiplatelets, anticoagulants
Other Name: aspirin
2
Patients who undergo percutaneous device closure
Device: percutaneous device closure of PFO
umbrella device for PFO closure
Other Name: clopidogrel

Detailed Description:

Background

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. Even if RCTs are completed successfully, statistical differences may remain undetected with the planned sample sizes. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates.

Objective

1) To compare the risk of recurrent stroke and TIA in patients aged ≤ 55 years with PFO and otherwise unexplained stroke who undergo PDC or receive ATT only; 2) To assess the etiological role of PFO for stroke/TIA in patients aged > 55 years; 3) To assess the risk of recurrent stroke/TIA in "high-risk" PFO patients (i.e. those with spontaneous (at rest) or large RLS, coinciding ASA, or multiple previous cerebrovascular events).

Methods

Multicenter prospective non-randomized study with scheduled 3-years follow-up of patients with PFO and ischemic stroke or TIA. Participating centers: Swiss University Hospitals of Basel, Bern, Geneva, Lausanne and Zurich, the Cantonal Hospital of Aarau, the Triemli Hospital, the Alfried-Krupp Krankenhaus of Essen, the University Hospital of Essen, the Klinikum Worms gGmbH, Tufts Medical Center, Baystate Medical Center, the East Medical Center Tyler, and the University Hospital of Leuven.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859885

Contacts
Contact: Krassen Nedeltchev, MD +41 62 838 66 75 Krassen.Nedeltchev@ksa.ch
Contact: Marie-Luise Mono, MD +41316320743 marie-luise.mono@insel.ch

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
United States, Texas
East Medical Center Recruiting
Tyler, Texas, United States, 75710
Belgium
University Hospital Gent Recruiting
Gent, Belgium, 9000
Contact: Dimitri Hemelsoet, MD         
Leuven University Hospital Recruiting
Leuven, Belgium, 3000
Germany
Essen University Hospital Recruiting
Essen, Germany, 45147
Alfried Krupp Hospital Recruiting
Essen, Germany, 45117
Ammerland Klinik GmbH Recruiting
Westerstede, Germany, 26655
Contact: Andreas Müller-Eichelberg, MD         
Klinikum Worms gGmbH Recruiting
Worms, Germany, 67550
Italy
Arcispedale Santa Maria Nuova Recruiting
Department of Neurology, ASMN IRCCS, Reggio Emilia, Italy, 42123
Spain
University Hospital Doctor Josep Trueta Recruiting
Girona, Spain, 17707
Contact: Joaquín Serena, MD         
Switzerland
Cantonal Hospital of Aarau Recruiting
Aarau, Switzerland, 5001
Basel University Hospital Recruiting
Basel, Switzerland, 4031
Department of Neurology, Bern University Hospital, Bern Recruiting
Bern, Switzerland, 3010
Contact: Marie-Luise Mono    +41316320743    marie-luise.mono@insel.ch   
Principal Investigator: Marie-Luise Mono, MD         
Sub-Investigator: Bernhard Meier, MD         
Sub-Investigator: Marcel Arnold, MD         
Geneva University Hospital Recruiting
Geneva, Switzerland, 1211
Lausanne University Hospital Recruiting
Lausanne, Switzerland, 1011
Zürich Triemli Hospital Recruiting
Zürich, Switzerland, 8063
Zürich University Hospital Recruiting
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital Inselspital, Berne
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
University Hospital, Geneva
University Hospital, Zürich
Triemli Hospital
Cantonal Hospital of Aarau, Switzerland
Alfried-Krupp Krankenhaus of Essen, Germany
University Hospital, Essen
Klinikum Worms gGmbH, Germany
Tufts Medical Center
Baystate Medical Center
East Medical Center Tyler, Texas
Universitaire Ziekenhuizen Leuven
Ammerland Klinik GmbH, Westerstede, Germany
University Hospital, Ghent
Arcispedale Santa Maria Nuova-IRCCS
Investigators
Principal Investigator: Krassen Nedeltchev, MD Kantonsspital Aarau
Principal Investigator: Marie-Luise Mono, MD Dep. of Neurology, Bern University Hospital, Bern
Study Director: Marcel Arnold, MD University of Bern, Inselspital
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. med. Krassen Nedeltchev, University of Bern and Triemli Hospital Zurich
ClinicalTrials.gov Identifier: NCT00859885     History of Changes
Other Study ID Numbers: 117/08
Study First Received: March 6, 2009
Last Updated: September 8, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
patent foramen ovale
ischemic stroke
transient ischemic attack
secondary prevention
medical treatment
percutaneous device closure

Additional relevant MeSH terms:
Stroke
Ischemic Attack, Transient
Foramen Ovale, Patent
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

ClinicalTrials.gov processed this record on September 29, 2014