Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale

This study is ongoing, but not recruiting participants.

Sponsored by:	Carag AG
Information provided by:	Carag AG
ClinicalTrials.gov Identifier:	NCT00207376

Purpose

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).

Condition	Intervention
Atrial Septal Defect Patent Foramen Ovale	Device: Solysafe Septal Occluder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Eligibility

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207376

Locations

Germany
German Heart Institute
Berlin, Germany, 13353

Sponsors and Collaborators

Carag AG

Investigators

Principal Investigator:

Peter Ewert, PD Dr.

German Heart Institute, Berlin

More Information

Study ID Numbers:	04k001
Study First Received:	September 13, 2005
Last Updated:	April 10, 2007
ClinicalTrials.gov Identifier:	NCT00207376
Health Authority:	Germany: LAGetSi, Berlin

Study placed in the following topic categories:

Heart Septal Defects
Heart Diseases
Congenital heart septum defect
Cardiovascular Abnormalities

Foramen Ovale, Patent
Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Atrial

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009