PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism - Full Text View

Sponsor:	Foundation for Cardiovascular Research, Zurich
Collaborator:	AGA Medical Corporation
Information provided by:	Foundation for Cardiovascular Research, Zurich
ClinicalTrials.gov Identifier:	NCT00166257

Purpose

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	Intervention	Phase
Embolism, Paradoxical Heart Septal Defects, Atrial	Device: Percutaneous closure of patent foramen ovale Drug: Medical antitrhombotic treatment	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism

Further study details as provided by Foundation for Cardiovascular Research, Zurich:

Primary Outcome Measures:

Time to death (Fatal stroke, cardiovascular, non-CV), [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
non-fatal cerebrovascular event, [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
peripheral embolism [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

New arrhythmias, [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
myocardial infarction [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
rehospitalization related to PFO or its treatment [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
device problems [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]
bleeding complications [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]

Enrollment:	414
Study Start Date:	February 2000
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Medical antitrhombotic treatment: Active Comparator	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
Device Implant: Experimental Percutaneous closure of patent foramen ovale	Device: Percutaneous closure of patent foramen ovale Percutaneous implantation of an AMPLATZER® PFO Occluder

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166257

Locations

Australia
Monash Medical Centre
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Alfred Hospital
Prahan, Australia
Austria
Universitätsklinik für Innere Medizin II
Vienna, Austria, 1090
Belgium
A.Z. Sint-Jan AV
Brugge, Belgium, 8000
Switzerland
University Hospital / Inselspital
Bern, Switzerland

Sponsors and Collaborators

Foundation for Cardiovascular Research, Zurich

AGA Medical Corporation

Investigators

Study Chair:

Bernhard Meier, MD

Dept. Cardiology, University Hospital Insel, Berne, Switzerland

More Information

No publications provided

Responsible Party:	University of Berne, Switzerland ( Meier, Bernhard, MD, Professor of Cardiology, )
Study ID Numbers:	ICN98008
Study First Received:	September 9, 2005
Last Updated:	May 26, 2009
ClinicalTrials.gov Identifier:	NCT00166257 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by Foundation for Cardiovascular Research, Zurich:

Paradoxical embolism, Patent foramen ovale,

Additional relevant MeSH terms:

Foramen Ovale, Patent
Embolism, Paradoxical
Embolism
Embolism and Thrombosis
Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities

Vascular Diseases
Thrombosis
Heart Septal Defects, Atrial
Thromboembolism
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital

ClinicalTrials.gov processed this record on February 08, 2010