ASSURED clinical study: New GORE® CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect

Objective Assess clinical performance of a new device for transcatheter closure of atrial septal defect (ASD). Background Previously-approved ASD Closure devices have known limitations. Device erosion has been associated with the AMPLATZER (R) septal occluder in patients with retro-aortic rim deficiency (<5 mm), while defects >= 18 mm are too large for the GORE (R) CARDIOFORM septal occluder. The GORE (R) CARDIOFORM ASD occluder (GCA), a hybrid of the approved devices, was designed to expand the eligible ASD population. Methods One-hundred and twenty-five ASD patients were enrolled in a prospective, multicenter registry. Descriptive clinical endpoints included: technical implant success, closure success, serious adverse events (SAE), clinically significant new arrhythmia, and wire frame fracture. Procedural outcomes and adverse events were adjudicated by an Echocardiography Core Lab and Independent Data Review Board, respectively. Results Median subject age was 12.3 years (range 2.9-84.7), with 72% of patients <= 18 years old. Median ASD stop-flow diameter was 17.0 mm (8.0-30.0), with 43% >= 18 mm. Deficient retro-aortic rim occurred in 57% of subjects, and 30% had both diameter >= 18 mm and deficient rim. Technical Implant Success was achieved in 120/125 (96%), though three devices were removed within 24 hr. At the scheduled 6-month evaluation, 112/117 returned for evaluation. All 112 had closure success. SAE occurred in 6/125 (4.8%) and 6/125 (4.8%) had clinically significant new arrhythmia. Wire frame fractures occurred in 37/104 (36%), without any associated clinical sequelae, residual shunt, or device instability. Conclusion The GCA performed effectively and safely in this initial cohort, and led to FDA approval based on this data.