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Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism
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
Details
| Lead sponsor | Foundation for Cardiovascular Research, Zurich |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 414 |
| Start date | 2000-02 |
| Completion | 2011-05 |
Conditions
- Embolism, Paradoxical
- Heart Septal Defects, Atrial
Interventions
- Percutaneous closure of patent foramen ovale
- Medical antitrhombotic treatment
Primary outcomes
- Time to death (Fatal stroke, cardiovascular, non-CV), — continuosly
- non-fatal cerebrovascular event, — continuosly
- peripheral embolism — continuosly
Countries
Australia, Austria, Belgium, Switzerland