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

This study has been completed.
Sponsor:
Information provided by:
Carag AG
ClinicalTrials.gov Identifier:
NCT00207376
First received: September 13, 2005
Last updated: June 23, 2009
Last verified: February 2007

September 13, 2005
June 23, 2009
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00207376 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
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)

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).

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Septal Defect
  • Patent Foramen Ovale
Device: Solysafe Septal Occluder
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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)
Both
3 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00207376
04k001
Not Provided
Not Provided
Carag AG
Not Provided
Principal Investigator: Peter Ewert, PD Dr. German Heart Institute, Berlin
Carag AG
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP