NCT00207376
Completed
N/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 (PFO)
Carag AG1 site in 1 countrySeptember 21, 2005
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Septal Defect
- Sponsor
- Carag AG
- Locations
- 1
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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 (PFO).
Investigators
Eligibility Criteria
Inclusion Criteria
- •PFO with a medical history of cryptogenic stroke due to presumed paradoxical embolism caused by a PFO
Exclusion Criteria
- •Criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (DIC), high risk of bleeding such as coagulation or clotting disorders)
Outcomes
Primary Outcomes
Not specified
Study Sites (1)
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