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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


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


Minimum age: 3 Years. Maximum age: N/A. Gender(s): Both.


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)

Locations and Contacts

German Heart Institute, Berlin 13353, Germany
Additional Information

Last updated: June 23, 2009

Page last updated: August 23, 2015

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