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

This study has been completed.

First Received: September 13, 2005 Last Updated: June 23, 2009 History of Changes

Sponsor:	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

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)

Resource links provided by NLM:

Drug Information available for: Statrol Neocidin Neosporin

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	04k001
Study First Received:	September 13, 2005
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00207376 History of Changes
Health Authority:	Germany: LAGetSi, Berlin

Additional relevant MeSH terms:

Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities
Foramen Ovale, Patent

Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Atrial

ClinicalTrials.gov processed this record on November 20, 2009