Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04291898
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2020-02-26
Brief Title:
Comparison of Devices for Atrial Septal Defects Closure A Pilot Study
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults A Pilot Study Trio-ASD
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Trio-ASD
Brief Summary:
This is a proposal for the first time in Canada to examine the comparative effectiveness of three commercially available devices ASO FSO and GAOGSO 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 GAOGSO to compare the effectiveness and safety outcomes of three different ASD closure devices
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 GAOGSO to compare the effectiveness and safety outcomes of three different ASD closure devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TrioASD | OTHER | UHN | None |