GORE Septal Occluder Clinical Study: A Study to evaluate safety and efficacy in treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs)
ID Number 13-1109Principal Investigator(s)
Barry A Love
Department(s) or Division(s)
The purpose of this study is to determine the safety and effectiveness of the GORE Septal Occluder when used to close atrial septal defects. This study device is being evaluated to see if it will close ASDs without surgery. Researchers will look to see if the study device decreases or stops blood flow between the atria, stops or reverses associated problems of the heart and lung, decreases hospital stay and shortens the time to full activity to a few days after the procedure. The ASD procedure is done during a heart test called a cardiac catheterization.
Recruiting Patients: Yes