In:
Catheterization and Cardiovascular Interventions, Wiley, Vol. 93, No. 2 ( 2019-02), p. 316-321
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1522-1946
,
1522-726X
Language:
English
Publisher:
Wiley
Publication Date:
2019
detail.hit.zdb_id:
2001555-0
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