Patent Foramen Ovale Clinical Trial
Official title:
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)
| NCT number | NCT00207376 |
| Other study ID # | 04k001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | September 13, 2005 |
| Last updated | June 23, 2009 |
| Verified date | February 2007 |
| Source | Carag AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: LAGetSi, Berlin |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 3 Years and older |
| Eligibility |
Inclusion Criteria: - ASD - 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) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | German Heart Institute | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Carag AG |
Germany,
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