Safety and Effectiveness Study of the Solysafe Septal Occluder

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2007 by Carag AG. Recruitment status was Active, not recruiting

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

Sponsor:	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:	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:

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

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

ClinicalTrials.gov Identifier:	NCT00353509 History of Changes
Other Study ID Numbers:	2006.1621
Study First Received:	July 16, 2006
Last Updated:	October 16, 2007
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

ClinicalTrials.gov processed this record on February 09, 2012