PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

Heart Septal Defects, Atrial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00166257
• Other study ID #: ICN98008
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: May 26, 2009
• Start date: February 2000
• Est. completion date: May 2011

Study information

• Verified date: May 2009
• Source: Foundation for Cardiovascular Research, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 414
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Embolism
• Embolism, Paradoxical
• Foramen Ovale, Patent
• Heart Septal Defects
• Heart Septal Defects, Atrial

Intervention

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

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Melbourne
Australia	Sir Charles Gairdner Hospital	Nedlands
Australia	Alfred Hospital	Prahan
Austria	Universitätsklinik für Innere Medizin II	Vienna
Belgium	A.Z. Sint-Jan AV	Brugge
Switzerland	University Hospital / Inselspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Cardiovascular Research, Zurich	St. Jude Medical

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death (Fatal stroke, cardiovascular, non-CV),		continuosly	Yes
Primary	non-fatal cerebrovascular event,		continuosly	Yes
Primary	peripheral embolism		continuosly	Yes
Secondary	New arrhythmias,		continuosly	Yes
Secondary	myocardial infarction		continuosly	Yes
Secondary	rehospitalization related to PFO or its treatment		continuosly	Yes
Secondary	device problems		continuosly	Yes
Secondary	bleeding complications		continuosly	Yes