Safety and Effectiveness Study of the Solysafe Septal Occluder

Atrial Septal Defects Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353509
• Other study ID #: 2006.1621
• Status: Completed
• Phase: N/A
• First received: July 16, 2006
• Last updated: October 8, 2013

Study information

• Verified date: October 2013
• Source: Carag AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Agency for Drugs and Medical Substances
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Septal Defects
• Heart Septal Defects
• Heart Septal Defects, Atrial

Intervention

Device:
• Device Closure of a Septal Defect

Locations

Country	Name	City	State
Serbia	University Childen's Hospital	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Carag AG

Country where clinical trial is conducted

Serbia,