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.
Catheter Cardiovasc Interv
; 93(2): 316-321, 2019 02 01.
Article
in En
| MEDLINE
| ID: mdl-30719850
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 ANDRESULTS:
Randomized, controlled, multi-center prospective clinical trial with randomization 21 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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Cardiac Catheterization
/
Septal Occluder Device
/
Heart Septal Defects, Atrial
Type of study:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Limits:
Adolescent
/
Adult
/
Aged
/
Child
/
Child, preschool
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
Catheter Cardiovasc Interv
Journal subject:
CARDIOLOGIA
Year:
2019
Type:
Article
Affiliation country:
Ireland