Status:
SUSPENDED
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
Lead Sponsor:
Cierra
Conditions:
Patent Foramen Ovale
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic at...
Detailed Description
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An asso...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years old
- Documented PFO
- Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness
Exclusion
- • Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00335296
Start Date
May 1 2006
End Date
December 1 2007
Last Update
December 24 2007
Active Locations (4)
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1
AZ Middleheim Hospital
Antwerp, Belgium
2
Institut Hospitalier Jacques Carter
Massy, France
3
Bichat Hospital
Paris, France, 75877
4
Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, Germany, 60389