Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale

Carag

Status: Completed

Conditions: Atrial Septal Defect; Patent Foramen Ovale

Treatments: Device: Solysafe Septal Occluder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00207376

04k001

Details and patient eligibility

About

This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale (PFO).

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASD
• PFO with a medical history of cryptogenic stroke due to presumed paradoxical embolism caused by a PFO

Exclusion criteria

• Criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (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)