Atrial Septal Defect Clinical Trial
Official title:
Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)
This is a proposal, for the first time in Canada, to examine the comparative effectiveness of three commercially available devices (ASO, FSO, and GAO/GSO) for transcatheter closure of atrial septal defects (ASD) in adults using a pilot randomized controlled trial.
The most widely used transcatheter device for ASD closure is the the Amplatzer Septal Occluder (ASO). Two other devices that entered the Canadian market are the Gore Cardioform ASD occluder (GAO) and the Figulla Flexible II Occlutech (FSO) device. There exists a paucity of data on the comparative efficacy and safety of these devices. This is a proposal, for the first time in Canada, to examine the comparative effectiveness of three commercially available ASD devices in an internal pilot randomized trial. Approximately 60 patients referred for transcatheter ASD closure will be recruited in this study over a period of 15 months from 4 participating centers across Canada. This will be a registry-based randomized controlled trial (RRCT) where patients will be enrolled into one of three arms (ASO, FSO, and GAO/GSO) to compare the effectiveness and safety outcomes of three different ASD closure devices. ;
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