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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
Author(s) -
Kenny Damien,
Eicken Andreas,
Dähnert Ingo,
Boudjemline Younes,
Sievert Horst,
Schneider Martin BE,
Gori Tommaso,
Hijazi Ziyad M.
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27899
Subject(s) - medicine , septum secundum , cardiac catheterization , surgery , heart septal defect , cardiology , single center
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.