Text Size

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
Sponsor:
Information provided by:
Carag AG
ClinicalTrials.gov Identifier:
NCT00353509
First received: July 16, 2006
Last updated: October 16, 2007
Last verified: October 2007
History of Changes
  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:

  • 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 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 May 23, 2013