Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atrial Septal Defect
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be randomly assigned to 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 to the device they receive. Healthcare providers or site coordinators cannot be blinded due to clear differences between devices.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 110 years
- Gender
- Both males and females
Description
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 Cardioform ASD occluder (GAO) and the Figulla Flexible II Occlutech (FSO) device. There exists a paucity of data on the comparative effi...
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 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.
Tracking Information
- NCT #
- NCT04291898
- Collaborators
- Montreal Heart Institute
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- St. Paul's Hospital, Canada
- Investigators
- Principal Investigator: Eric Horlick, MD University Health Network, Peter Munk Cardiac Centre Principal Investigator: Lusine Abrahamyan, MD, PhD University Health Network, Theta Collaborative
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