Safety and Effectiveness Study of the Solysafe Septal Occluder

This study is ongoing, but not recruiting participants.

Sponsored by:	Carag AG
Information provided by:	Carag AG
ClinicalTrials.gov Identifier:	NCT00353509

Purpose

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

MedlinePlus related topics: Infectious Mononucleosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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 ClinicalTrials.gov identifier: NCT00353509

Locations

Serbia and Montenegro
University Childen's Hospital
Belgrade, Serbia and Montenegro, 11000

Sponsors and Collaborators

Carag AG

Investigators

Principal Investigator:

Ida Jovanovic, Prof. Dr.

University Children's Hospital Belgrade

More Information

Study ID Numbers:	2006.1621
Study First Received:	July 16, 2006
Last Updated:	October 16, 2007
ClinicalTrials.gov Identifier:	NCT00353509
Health Authority:	Serbia: Agency for Drugs and Medical Substances

Study placed in the following topic categories:

Heart Septal Defects
Heart Diseases
Congenital heart septum defect
Cardiovascular Abnormalities

Infectious Mononucleosis
Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Atrial

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009