Safety and Effectiveness Study of the Solysafe Septal Occluder

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: NCT00353509
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : October 9, 2013
Information provided by (Responsible Party):
Carag AG

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Septal Defects Device: Device Closure of a Septal Defect Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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)

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): NCT00353509

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

Responsible Party: Carag AG Identifier: NCT00353509     History of Changes
Other Study ID Numbers: 2006.1621
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities