Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
Information source: Carag AG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Septal Defect; Patent Foramen Ovale
Intervention: Solysafe Septal Occluder (Device)
Phase: N/A
Status: Completed
Sponsored by: Carag AG Official(s) and/or principal investigator(s):
Peter Ewert, PD Dr., Principal Investigator, Affiliation: German Heart Institute, Berlin
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).
Clinical Details
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)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: 3 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
German Heart Institute, Berlin 13353, Germany
Additional Information
Last updated: June 23, 2009
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