PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

• Status: Unknown status
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Foundation for Cardiovascular Research, Zurich
• Collaborators: Abbott Medical Devices; St. Jude Medical

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