Heart Septal Defects, Atrial Clinical Trial
Official title:
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
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:
1. 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.
2. 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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