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
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
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

No publications provided

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 April 16, 2014