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Safety and Effectiveness Study of the Solysafe Septal Occluder

This study has been completed.
Information provided by (Responsible Party):
Carag AG Identifier:
First received: July 16, 2006
Last updated: October 8, 2013
Last verified: October 2013
Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)

Condition Intervention
Atrial Septal Defects
Device: Device Closure of a Septal Defect

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Mono-center Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device in Patients With Atrial Septum Defect (ASD)

Further study details as provided by Carag AG:


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASD

Exclusion Criteria:

  • Criteria that exclude catheterization (e.g. too small size, DIC, high risk of bleeding such as coagulation or clotting disorders)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00353509

University Childen's Hospital
Belgrade, Serbia, 11000
Sponsors and Collaborators
Carag AG
Principal Investigator: Ida Jovanovic, Prof. Dr. University Children's Hospital Belgrade
  More Information

Responsible Party: Carag AG Identifier: NCT00353509     History of Changes
Other Study ID Numbers: 2006.1621 
Study First Received: July 16, 2006
Last Updated: October 8, 2013
Health Authority: Serbia: Agency for Drugs and Medical Substances

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on October 21, 2016