DEFECT LÀ GÌ

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This is a proposal, for the first time in Canada, lớn examine the comparative sầu effectiveness of three commercially available atrial septal defect (ASD) devices in an internal pilot randomized trial.

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Condition or disease Intervention/treatment Phase
Atrial Septal Defect Device: AMPLATZER™ Septal Occluder. Device: Occlutech Figulla Flex II® Device: GORE® CARDIOFORM ASD Occluder Not Applicable

The most widely used transcatheter device for ASD closure is the the Amplatzer Septal Occluder (ASO). Two new devices that entered the Canadian market are the Gore Cardiokhung ASD occluder (GAO) and the Figulla Flexible II Occlutech (FSO) device. There exists a paucity of data on the comparative efficacy & safety of these devices. This is a proposal, for the first time in Canada, lớn 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, và GAO/GSO) khổng lồ compare the effectiveness and safety outcomes of three different ASD closure devices.

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Study Type : Interventional (Clinical Trial)
EstimatedEnrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly assigned khổng lồ one of three arms for the duration of the study. The arms include: ASO, FSO, GAO/GSO which indicate the type of intervention they will be receiving.
Masking: Single (Outcomes Assessor)
Masking Description: Patients will be blinded khổng lồ the device they receive. Healthcare providers or site coordinators cannot be blinded due to lớn clear differences between devices.
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts và Locations More Information