Trial | NCT00166257  Report issue

Title

PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism
Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    414
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
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:

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.
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.
Study Started
Feb 29
2000
Primary Completion
Feb 28
2011
Anticipated
Study Completion
May 31
2011
Anticipated
Last Update
May 27
2009
Estimate

Device Percutaneous closure of patent foramen ovale

Percutaneous implantation of an AMPLATZER® PFO Occluder

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

Medical antitrhombotic treatment Active Comparator

Device Implant Experimental

Percutaneous closure of patent foramen ovale

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
No Results Posted