This clinical trial is for men and women diagnosed with an atrial septal defect, which is an opening between the right and left upper chambers of the heart. As part of this study, the doctor will attempt to implant the AMPLATZER™ Septal Occluder (ASO) to close this hole. The ASO is approved by the FDA to close atrial septal defects. The device, procedures and tests used in this study are not considered experimental.
The purpose of the study is to gather more information about the possible risk factors associated with the occurrence of a rare type of negative effect, called erosion, and the presence of the implanted ASO device.
Study subjects will be followed up for 12 months after the placement of the ASO.
Men and women age 18 and older who meet clinical standards for atrial septal defect closure may enroll in the study.
Detailed eligibility requirements will be reviewed when you contact the study team.
Dolores Reynolds, R.N., phone 212-746-4617, email email@example.com
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study (ASO 522). ClinicalTrials.gov Identifier NCT02353351