Safety and Effectiveness Study of the Solysafe Septal Occluder

Carag

Status: Completed

Conditions: Atrial Septal Defects

Treatments: Device: Device Closure of a Septal Defect

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353509

2006.1621

Details and patient eligibility

About

Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)