Clinical trial NCT00166257: PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism
Official title: Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Embolism, Paradoxical
Heart Septal Defects, Atrial
Keywords: Paradoxical embolism, Patent foramen ovale,
Lead sponsor: Foundation for Cardiovascular Research, Zurich
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2005-09-14
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 persistent small opening between the upper heart chambers

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 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

Primary outcomes:
measure: Time to death (Fatal stroke, cardiovascular, non-CV),
timeFrame: continuosly
measure: non-fatal cerebrovascular event,
timeFrame: continuosly
measure: peripheral embolism
timeFrame: continuosly
Secondary outcomes:
measure: New arrhythmias,
timeFrame: continuosly
measure: myocardial infarction
timeFrame: continuosly
measure: rehospitalization related to PFO or its treatment
timeFrame: continuosly
measure: device problems
timeFrame: continuosly
measure: bleeding complications
timeFrame: continuosly
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Monash Medical Centre
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Prahan
country: Australia
facility: Alfred Hospital
city: Vienna
country: Austria
facility: Universitätsklinik für Innere Medizin II
city: Brugge
country: Belgium
facility: A.Z. Sint-Jan AV
city: Bern
country: Switzerland
facility: University Hospital / Inselspital
Study officials:
affiliation: Dept. Cardiology, University Hospital Insel, Berne, Switzerland
name: Bernhard Meier, MD
role: STUDY_CHAIR
References:
citation: Meier B, Kalesan B, Mattle HP, Khattab AA, Hildick-Smith D, Dudek D, Andersen G, Ibrahim R, Schuler G, Walton AS, Wahl A, Windecker S, Juni P; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med. 2013 Mar 21;368(12):1083-91. doi: 10.1056/NEJMoa1211716.
citation: Khattab AA, Windecker S, Juni P, Hildick-Smith D, Dudek D, Andersen HR, Ibrahim R, Schuler G, Walton AS, Wahl A, Mattle HP, Meier B. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design. Trials. 2011 Feb 28;12:56. doi: 10.1186/1745-6215-12-56.