ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study

This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects,
randomly selected from the full cohort. The analysis population will consist of all subjects
in the sub-cohort, combined with all subjects with erosion events who are not in the
sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this
analysis population.

Inclusion Criteria:

To participate in this clinical investigation, the patient must meet all of the following
inclusion criteria:

1. Patient indicated for ASD closure who has echocardiographic evidence of ostium
secundum atrial septal defect and clinical evidence of right ventricular volume
overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is
implanted with the ASO device Note: This does not include the indication for closure
of a fenestration following a fenestrated Fontan procedure

2. Patient is willing and able to complete the follow-up requirements of this study

3. Patient signs the informed consent (or a legal representative signs the informed
consent.)

Exclusion Criteria:

Patient is not eligible for clinical investigation participation if he/she meets any of the
following exclusion criteria:

1. Patient is known to have extensive congenital cardiac anomaly which can only be
adequately repaired by way of cardiac surgery

2. Patient is known to have sepsis within 1 month prior to implantation, or any systemic
infection that cannot be successfully treated prior to device placement

3. Patient is known to have a bleeding disorder, untreated ulcer, or any other
contraindications to aspirin therapy (unless another anti-platelet agent can be
administered for 6 months)

4. Patient is known to have a demonstrated intracardiac thrombus on echocardiography

5. Patient whose size (such as, too small for transesophageal echocardiography probe,
catheter size) or condition (active infection, etc.) would cause the patient to be a
poor candidate for cardiac catheterization

6. Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves
or right upper lobe pulmonary vein