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Sponsors and Collaborators: |
Foundation for Cardiovascular Research, Zurich AGA Medical Corporation |
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Information provided by: | Foundation for Cardiovascular Research, Zurich |
ClinicalTrials.gov Identifier: | NCT00166257 |
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 |
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 |
Estimated Enrollment: | 500 |
Study Start Date: | February 2000 |
Estimated Study Completion Date: | December 2007 |
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:
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study Chair: | Bernhard Meier, MD | Dept. Cardiology, University Hospital Insel, Berne, Switzerland |
Study ID Numbers: | ICN98008 |
Study First Received: | September 9, 2005 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00166257 |
Health Authority: | Switzerland: Swissmedic |
Paradoxical embolism, Patent foramen ovale, |
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 |
Cardiovascular Diseases |