PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism
Embolism, Paradoxical, Heart Septal Defects, Atrial
About this trial
This is an interventional prevention trial for Embolism, Paradoxical focused on measuring Paradoxical embolism, Patent foramen ovale,
Eligibility 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
Sites / Locations
- Monash Medical Centre
- Sir Charles Gairdner Hospital
- Alfred Hospital
- Universitätsklinik für Innere Medizin II
- A.Z. Sint-Jan AV
- University Hospital / Inselspital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Medical antitrhombotic treatment
Device Implant
Percutaneous closure of patent foramen ovale