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

Sponsors and Collaborators:	Foundation for Cardiovascular Research, Zurich 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	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Factorial 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),
non-fatal cerebrovascular event,
peripheral embolism

Secondary Outcome Measures:

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

Estimated Enrollment:	500
Study Start Date:	February 2000
Estimated Study Completion Date:	December 2007

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

Contacts

Contact: Bernhard Meier, Prof., MD	+41 31 632 30 77	Bernhard.Meier@insel.ch
Contact: Heinrich Mattle, Prof., MD	+41 31 632 3332	heinrich.mattle@insel.ch

Locations

Australia
Monash Medical Centre	Recruiting
Melbourne, Australia
Contact: Samuel Menahem, MD
Principal Investigator: Samuel Menahem, MD
Sir Charles Gairdner Hospital	Recruiting
Nedlands, Australia
Contact: Trish Taafe, RN
Principal Investigator: Bernard EF Hockings, MD
Alfred Hospital	Recruiting
Prahan, Australia
Contact: Tony Walton, MD
Principal Investigator: Tony Walton, MD
Austria
Universitätsklinik für Innere Medizin II	Recruiting
Vienna, Austria, 1090
Contact: Peter Probst, MD +43 1 404 4616
Contact: Wolfgang Lalouschek, MD +43 1 404 3110
Sub-Investigator: Helmuth Baumgartner, MD
Belgium
A.Z. Sint-Jan AV	Recruiting
Brugge, Belgium, 8000
Contact: Geert Vanhooren, MD
Contact: Valerie Schotte, RN +31 50 45 23 06
Principal Investigator: Gert Vanhooren, MD
Switzerland
University Hospital / Inselspital	Recruiting
Bern, Switzerland
Contact: B Meier, MD
Contact: H Mattle, MD
Principal Investigator: B. Meier, MD
Principal Investigator: Heinrich Mattle, MD

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

Study ID Numbers:	ICN98008
Study First Received:	September 9, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00166257
Health Authority:	Switzerland: Swissmedic

Keywords provided by Foundation for Cardiovascular Research, Zurich:

Paradoxical embolism, Patent foramen ovale,

Study placed in the following topic categories:

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

Embolism and Thrombosis
Congenital heart septum defect
Embolism
Foramen Ovale, Patent
Embolism, Paradoxical
Congenital Abnormalities
Heart Defects, Congenital

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009