A randomized, controlled, multi-center trial of the efficacy and safety of the Occlutech Figulla Flex-II Occluder compared to the Amplatzer Septal Occluder for transcatheter closure of secundum atrial septal defects
Catheterization and Cardiovascular Interventions Nov 08, 2018
Kenny D, et al. - In patients > 8kg undergoing transcatheter ASD closure, the Occlutech Figulla Flex II Occluder (OFFII) was compared with the Amplatzer Septal Occluder (ASO) in terms of effectiveness and safety in this randomized, controlled, multi-center prospective clinical trial with randomization 2:1 of 176 participants in favor of the OFFII. The main outcome of interest was the rate of successful device placement and defect closure without major complications at hospital discharge. Data analysis was carried out through a core laboratory. According to findings, the OFFII device vs the ASO offered less complications and greater efficacy, so the OFFII device was not inferior to the ASO.
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