PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

Sponsor

Foundation for Cardiovascular Research, Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT00166257

Collaborator

Abbott Medical Devices (Industry)

414

Enrollment

Locations

Arms

134.9

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Embolism, Paradoxical Heart Septal Defects, Atrial	Device: Percutaneous closure of patent foramen ovale Drug: Medical antitrhombotic treatment	Phase 4

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

414 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Feb 1, 2000

Anticipated Primary Completion Date :

Feb 1, 2011

Anticipated Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medical antitrhombotic treatment	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
Experimental: Device Implant Percutaneous closure of patent foramen ovale	Device: Percutaneous closure of patent foramen ovale Percutaneous implantation of an AMPLATZER® PFO Occluder

Arm

Intervention/Treatment

Active Comparator: Medical antitrhombotic treatment

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

Experimental: Device Implant

Percutaneous closure of patent foramen ovale

Device: Percutaneous closure of patent foramen ovale

Percutaneous implantation of an AMPLATZER® PFO Occluder

Outcome Measures

Primary Outcome Measures

Time to death (Fatal stroke, cardiovascular, non-CV), [continuosly]
non-fatal cerebrovascular event, [continuosly]
peripheral embolism [continuosly]

Secondary Outcome Measures

New arrhythmias, [continuosly]
myocardial infarction [continuosly]
rehospitalization related to PFO or its treatment [continuosly]
device problems [continuosly]
bleeding complications [continuosly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Monash Medical Centre	Melbourne	Australia
2	Sir Charles Gairdner Hospital	Nedlands	Australia
3	Alfred Hospital	Prahan	Australia
4	Universitätsklinik für Innere Medizin II	Vienna	Austria	1090
5	A.Z. Sint-Jan AV	Brugge	Belgium	8000
6	University Hospital / Inselspital	Bern	Switzerland