We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00166257
Previous Study | Return to List | Next Study

PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00166257
Recruitment Status : Unknown
Verified May 2009 by Foundation for Cardiovascular Research, Zurich.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2005
Last Update Posted : May 27, 2009
Abbott Medical Devices
Information provided by:
Foundation for Cardiovascular Research, Zurich

Brief Summary:
The purpose of this study is to compare two treatments strategies to prevent further attacks in patients who have suffered an stroke or occlusion of a major artery with no obvious reason other than a persistent small opening between the upper heart chambers

Condition or disease Intervention/treatment Phase
Embolism, Paradoxical Heart Septal Defects, Atrial Device: Percutaneous closure of patent foramen ovale Drug: Medical antitrhombotic treatment Phase 4

Detailed Description:

In patients who have suffered a stroke or occlusion of a large artery in another body part of unknown origin a possible cause is a small opening between the upper heart chambers (patent foramen ovale, it is called). After birth this opening closes in 75% of the population, while it persists in 25% of people. It may allow a small blood clot to pass from the veins of the legs through the heart into the brain or other parts of the body. In order to reduce the risk for a further attack we have today more therapeutic options to choose from but it is unclear which strategy have the best outcome. This study is created to compare the effect of two treatment strategies:

  1. Medical treatment The purpose of medical treatment is to dilute the blood to a degree, that no thrombus formation occurs. Since the opening in the heart persists, treatment is usually recommended lifelong. And patients treated with coumadin must undergo regular blood tests to ensure an adequate effect of the drug.
  2. Catheter closure of patent foramen ovale An alternative method developed to close the small opening in the heart utilizes catheters which are introduced in a blood vessel in the groin and from there advanced to the heart. An umbrella device is then delivered through the catheter, positioned within the small defect and released. The umbrella is overgrown with own tissue within weeks to months and closes the small defect for ever.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism
Study Start Date : February 2000
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : May 2011

Arm Intervention/treatment
Active Comparator: Medical antitrhombotic treatment Drug: Medical antitrhombotic treatment
Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d

Experimental: Device Implant
Percutaneous closure of patent foramen ovale
Device: Percutaneous closure of patent foramen ovale
Percutaneous implantation of an AMPLATZER® PFO Occluder

Primary Outcome Measures :
  1. Time to death (Fatal stroke, cardiovascular, non-CV), [ Time Frame: continuosly ]
  2. non-fatal cerebrovascular event, [ Time Frame: continuosly ]
  3. peripheral embolism [ Time Frame: continuosly ]

Secondary Outcome Measures :
  1. New arrhythmias, [ Time Frame: continuosly ]
  2. myocardial infarction [ Time Frame: continuosly ]
  3. rehospitalization related to PFO or its treatment [ Time Frame: continuosly ]
  4. device problems [ Time Frame: continuosly ]
  5. bleeding complications [ Time Frame: continuosly ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age below 60 years
  • Ischemic stroke or peripheral thromboembolism, radiologically verified
  • Absence of an identifiable cause of embolism
  • Echocardiographically verified patent foramen ovale
  • Sufficient recovery from index event to allow independent daily activities

Exclusion Criteria:

  • Any identifiable cause for thromboembolic event other than PFO
  • Cardiac diseases: mural thrombus, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis, atrial fibrillation
  • Vascular system: significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis
  • Pre-existing neurologic disorders or intracranial disease, e.g., multiple sclerosis, arteriovenous malformations, previous hemorrhage
  • Contraindications for antithrombotic or anticoagulant therapy
  • Patients already on chronic anticoagulant therapy for another disease
  • Previous surgical or percutaneous PFO-closure
  • Drug or alcohol abuse
  • Pregnancy
  • Septicemia or severe infectious disease
  • Severe CNS disease
  • No informed consent
  • Foreseen difficulties with study compliance, especially the long-term follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166257

Layout table for location information
Monash Medical Centre
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Alfred Hospital
Prahan, Australia
Universitätsklinik für Innere Medizin II
Vienna, Austria, 1090
A.Z. Sint-Jan AV
Brugge, Belgium, 8000
University Hospital / Inselspital
Bern, Switzerland
Sponsors and Collaborators
Foundation for Cardiovascular Research, Zurich
Abbott Medical Devices
Layout table for investigator information
Study Chair: Bernhard Meier, MD Dept. Cardiology, University Hospital Insel, Berne, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Meier, Bernhard, MD, Professor of Cardiology,, University of Berne, Switzerland
ClinicalTrials.gov Identifier: NCT00166257    
Other Study ID Numbers: ICN98008
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: May 27, 2009
Last Verified: May 2009
Keywords provided by Foundation for Cardiovascular Research, Zurich:
Paradoxical embolism, Patent foramen ovale,
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Septal Defects
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Embolism, Paradoxical
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities