Status:
UNKNOWN
PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism
Lead Sponsor:
Foundation for Cardiovascular Research, Zurich
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Embolism, Paradoxical
Heart Septal Defects, Atrial
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 ...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT00166257
Start Date
February 1 2000
End Date
May 1 2011
Last Update
May 27 2009
Active Locations (6)
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1
Monash Medical Centre
Melbourne, Australia
2
Sir Charles Gairdner Hospital
Nedlands, Australia
3
Alfred Hospital
Prahan, Australia
4
Universitätsklinik für Innere Medizin II
Vienna, Austria, 1090