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.

Kenny, Damien; Eicken, Andreas; Dähnert, Ingo; Boudjemline, Younes; Sievert, Horst; Schneider, Martin Be; Gori, Tommaso; Hijazi, Ziyad M

doi:10.1002/ccd.27899

2019

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Title:: 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.
Document type:: Article; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
Author(s):: Kenny, Damien; Eicken, Andreas; Dähnert, Ingo; Boudjemline, Younes; Sievert, Horst; Schneider, Martin Be; Gori, Tommaso; Hijazi, Ziyad M
Abstract:: AIMS: The aim of this study was to compare the efficacy and safety of the Occlutech Figulla Flex II Occluder (OFFII) with the Amplatzer Septal Occluder (ASO) in patients > 8kg undergoing transcatheter ASD closure. METHODS AND RESULTS: Randomized, controlled, multi-center prospective clinical trial with randomization 2:1 in favor of the OFFII. Primary efficacy endpoint was the rate of successful device placement and defect closure without major complications at hospital discharge. All data were assessed through a core laboratory. Interim analysis was performed when 70% of the patients were treated to evaluate for noninferiority. From a total of 176 randomized subjects, interim analysis was performed on the first 158 patients (65.2% female) (107 OFFII/51 ASO) undergoing device closure at a median weight of 42 kg (range 13-125 kg). Seventy-six percent (120 patients) completed 6-month follow-up. Successful device placement (first attempt) was achieved in 99.1% of the OFF group vs 90.2% of the ASO group (P < 0.05). Early efficacy success was achieved in 94.4% of the OFFII group vs 90.2% of the ASO group (P < 0.001). The incidence of major complications was 5.6% for the OFFII group compared to 9.8% for the ASO. CONCLUSIONS: The OFFII device was not inferior to the ASO with less complications and greater efficacy than the ASO.
Journal title abbreviation:: Catheter Cardiovasc Interv
Year:: 2019
Journal volume:: 93
Journal issue:: 2
Pages contribution:: 316-321
Fulltext / DOI:: doi:10.1002/ccd.27899
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/30719850
Print-ISSN:: 1522-1946
TUM Institution:: Klinik für Kinderkardiologie und angeborene Herzfehler (Prof. Hess)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Lehr- und Forschungskooperationen mit den Kliniken und Instituten am Deutschen Herzzentrum Klinik für Kinderkardiologie und angeborene Herzfehler (DHM) (Prof. Ewert)2019