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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00207376
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 24, 2009
Information provided by:
Carag AG

Brief 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).

Condition or disease Intervention/treatment Phase
Atrial Septal Defect Patent Foramen Ovale Device: Solysafe Septal Occluder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00207376

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German Heart Institute
Berlin, Germany, 13353
Sponsors and Collaborators
Carag AG
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Principal Investigator: Peter Ewert, PD Dr. German Heart Institute
Layout table for additonal information Identifier: NCT00207376    
Other Study ID Numbers: 04k001
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: February 2007
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities