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Catheter Cardiovasc Interv. 2019 Feb 1;93(2):316-321. doi: 10.1002/ccd.27899. Epub 2018 Nov 4.

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 information

1
Department of Cardiology, Our Lady's Children's Hospital, Dublin, Ireland.
2
German Heart Center, Munich, Germany.
3
Department of Pediatric Cardiology Heart Centre, University of Leipzig, Leipzig, Germany.
4
Department of Pediatric Cardiology, Centre de reference des Malformations Cardiaques Congénitales Complexes, Necker Hospital, Paris, France.
5
CardioVascular Center Frankfurt, Frankfurt, Germany & Anglia Ruskin University, Chelmsford, United Kingdom.
6
Department of Pediatric Cardiology, Charitè Medical Center, Humboldt University, Berlin, Germany.
7
Zentrum für Kardiologie, Kardiologie I, University Medical Center, and DZHK Standort Rhein-Main, Mainz, Germany.
8
Sidra Cardiovascular Center of Excellence, Weil Cornell Medical College, Doha, Qatar.

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.

KEYWORDS:

atrial septal defect; closure; device; transcatheter

PMID:
30719850
DOI:
10.1002/ccd.27899

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