Clinical Trial: PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism

Brief Summary: 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

Detailed Summary:

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.

Sponsor: Foundation for Cardiovascular Research, Zurich

Current Primary Outcome:

  • Time to death (Fatal stroke, cardiovascular, non-CV), [ Time Frame: continuosly ]
  • non-fatal cerebrovascular event, [ Time Frame: continuosly ]
  • peripheral embolism [ Time Frame: continuosly ]


Original Primary Outcome:

  • Time to death (Fatal stroke, cardiovascular, non-CV),
  • non-fatal cerebrovascular event,
  • peripheral embolism


Current Secondary Outcome:

  • New arrhythmias, [ Time Frame: continuosly ]
  • myocardial infarction [ Time Frame: continuosly ]
  • rehospitalization related to PFO or its treatment [ Time Frame: continuosly ]
  • device problems [ Time Frame: continuosly ]
  • bleeding complications [ Time Frame: continuosly ]


Original Secondary Outcome:

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


Information By: Foundation for Cardiovascular Research, Zurich

Dates:
Date Received: September 9, 2005
Date Started: February 2000
Date Completion: May 2011
Last Updated: May 26, 2009
Last Verified: May 2009