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

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ClinicalTrials.gov Identifier: NCT00207376
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 24, 2009
Sponsor:
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
Atrial Septal Defect Patent Foramen Ovale Device: Solysafe Septal Occluder

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)




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

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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00207376     History of Changes
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:
Heart Septal Defects
Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities