Safety and Effectiveness Study of the Solysafe Septal Occluder

This study is ongoing, but not recruiting participants.

First Received: July 16, 2006 Last Updated: October 16, 2007 History of Changes

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

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

No publications provided

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

Study placed in the following topic categories:

Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities
Congenital Heart Septum Defect

Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Atrial

Additional relevant MeSH terms:

Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases

Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Atrial

ClinicalTrials.gov processed this record on September 03, 2009