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PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Foundation for Cardiovascular Research, Zurich.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
AGA Medical Corporation
Information provided by:
Foundation for Cardiovascular Research, Zurich
ClinicalTrials.gov Identifier:
NCT00166257
First received: September 9, 2005
Last updated: May 26, 2009
Last verified: May 2009
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Foundation for Cardiovascular Research, Zurich:

Primary Outcome Measures:
  • Time to death (Fatal stroke, cardiovascular, non-CV), [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
  • non-fatal cerebrovascular event, [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
  • peripheral embolism [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • New arrhythmias, [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
  • rehospitalization related to PFO or its treatment [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
  • device problems [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
  • bleeding complications [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]

Enrollment: 414
Study Start Date: February 2000
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166257

Locations
Australia
Monash Medical Centre
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Alfred Hospital
Prahan, Australia
Austria
Universitätsklinik für Innere Medizin II
Vienna, Austria, 1090
Belgium
A.Z. Sint-Jan AV
Brugge, Belgium, 8000
Switzerland
University Hospital / Inselspital
Bern, Switzerland
Sponsors and Collaborators
Foundation for Cardiovascular Research, Zurich
AGA Medical Corporation
Investigators
Study Chair: Bernhard Meier, MD Dept. Cardiology, University Hospital Insel, Berne, Switzerland
  More Information

No publications provided by Foundation for Cardiovascular Research, Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Meier, Bernhard, MD, Professor of Cardiology,, University of Berne, Switzerland
ClinicalTrials.gov Identifier: NCT00166257     History of Changes
Other Study ID Numbers: ICN98008
Study First Received: September 9, 2005
Last Updated: May 26, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Foundation for Cardiovascular Research, Zurich:
Paradoxical embolism, Patent foramen ovale,

Additional relevant MeSH terms:
Embolism
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Embolism, Paradoxical
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Thromboembolism
Thrombosis

ClinicalTrials.gov processed this record on June 17, 2013