Status:
COMPLETED
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
Lead Sponsor:
Carag AG
Conditions:
Atrial Septal Defect
Patent Foramen Ovale
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale ...
Eligibility Criteria
Inclusion
- ASD
- PFO with a medical history of cryptogenic stroke due to presumed paradoxical embolism caused by a PFO
Exclusion
- Criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (DIC), high risk of bleeding such as coagulation or clotting disorders)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00207376
Last Update
June 24 2009
Active Locations (1)
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1
German Heart Institute
Berlin, Germany, 13353