Treating Atrial Septal Defects with Amplatzer

Closure of Atrial Septal Defects with the Amplatzer® Septal Occluder Post Market Study

Protocol Description

The purpose of this multi-center study is to gather more information about how effective the Amplatzer® Septal Occluder is at closing atrial septal defects (ASD). An ASD is an opening in the wall that divides the upper chamber of the heart. The Amplatzer device is an expandable disc that is placed into the heart via cardiac catheterization.

Eligibility Criteria

Subject to certain baseline testing, eligible candidates include male and female babies and children diagnosed with an ASD condition that would benefit from closure with a septal occluder.
Boys: All ages
Girls: All ages

Requirements

Following baseline testing for eligibility, patients will receive the implant procedure through the catheterization lab in a non-surgical procedure. During the first 6 months following the procedure, patients may be required to take aspirin and antibiotics. Additional testing may be required over the 2-year follow-up period.
Visits: Requires hospital visit
Duration: 2 years

Status: Closed to Enrollment

Source(s) of Support

AGA Medical Corporation

Primary Investigator

Jacqueline Kreutzer, MD, FACC, FSCAI

Contact Information

For information, please contact:
Jane Luce, MPH, CHES
412-692-6762