NCT04291898

Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study

Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atrial Septal Defect

Interventions

Type	Name	Description
DEVICE	AMPLATZER™ Septal Occluder.	Implantation of the AMPLATZER™ Septal Occluder in the ASD.
DEVICE	Occlutech Figulla Flex II®	Implantation of the Occlutech Figulla Flex II® in the ASD.
DEVICE	GORE® CARDIOFORM ASD Occluder	Implantation of the GORE® CARDIOFORM ASD Occluder or GORE® CARDIOFORM Septal Occluder in the ASD.

Timeline

• Start date: 2022-11-23
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2020-03-02
• Last updated: 2023-04-06

Locations

4 sites across 1 country: Canada