Safety and Effectiveness Study of the Solysafe Septal Occluder

Not Applicable

Completed

• Conditions: Atrial Septal Defects

• Registration Number: NCT00353509
• Lead Sponsor: Carag AG

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-16
• Study First Submitted QC: 2006-07-16
• Study First Posted: 2006-07-18
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University Childen's Hospital; 🇷🇸 Belgrade, Serbia