Table 1

Exclusion Criteria for the ASO Pivotal Study

Exclusion Criteria for Both Groups
Presence of associated congenital cardiac anomalies requiring surgical repair
Primum ASD
Sinus venosus ASD (including partial anomalous pulmonary venous drainage)
Pulmonary vascular resistance >7 Woods units
Right-to-left shunt at the atrial level with peripheral arterial saturation <94%
Recent myocardial infarction
Unstable angina, decompensated congestive heart failure, or right and/or left ventricular decompensation with ejection fraction of <30%
History of repeated pulmonary infection
Any type of serious infection <1 month before the procedure
Malignancy where life expectancy was <2 yrs
Intracardiac thrombi
Weight <8 kg
Inability to obtain informed consent
Other contraindications to aspirin or other antiplatelet agents

Reprinted, with permission, from Du et al. (9).

ASD = atrial septal defect(s); ASO = Amplatzer septal occluder.

  • An additional exclusion criterion for the device group was patients with multiple defects that could not be adequately covered by device(s).