An interventional study of AMPLATZER™ Septal Occluder. and Occlutech Figulla Flex II® in Atrial Septal Defect, sponsored by University Health Network, Toronto. Status unknown at 4 sites in Canada. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 51 interventional studies indexed under Heart Septal Defects.
Browse Heart Septal Defects studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants implanted with the AMPLATZER™ Septal Occluder (ASO)
Device: AMPLATZER™ Septal Occluder.
Participants implanted with the Occlutech Figulla Flex II® (FSO).
Device: Occlutech Figulla Flex II®
Participants implanted with the GORE® CARDIOFORM ASD Occluder (GSO/GAO)
Device: GORE® CARDIOFORM ASD Occluder
Implantation of the AMPLATZER™ Septal Occluder in the ASD.
Implantation of the Occlutech Figulla Flex II® in the ASD.
Implantation of the GORE® CARDIOFORM ASD Occluder or GORE® CARDIOFORM Septal Occluder in the ASD.
Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE)
At 24 weeks where clinical (AF) includes AF-related, ECG-documented, ED visit/hospitalization/physician visit, cardioversion, ablation or pacemaker implantation or new antiarrhythmic or AF anticoagulant prescription'; MACCE includes 'new onset heart failure (HF), HF-related ED admission, myocardial infarction, stroke, re-intervention, or death.
Time frame: 24 weeks
Subclinical AF (SCAF) burden (days):
Days with \>6 min of AF detected on CardioSTAT monitor during 14 days
Time frame: 14 days
Subclinical AF (SCAF) burden (number of episodes):
Number of episodes with \>6 min of AF detected on CardioSTAT monitor during 14 days
Time frame: 14 days
Subclinical AF (SCAF) burden (total time):
Total time in AF during 14 days
Time frame: 14 days
Subclinical AF (SCAF) burden (percent time):
Percent time in AF during 14 days
Time frame: 14 days
Procedural effectiveness outcomes (acute technical success rate at discharge)
Successful deployment and retention without major device related complications, stroke, myocardial infarction (MI) or arrhythmia requiring antiarrhythmic drug or cardioversion
Time frame: Discharge, 24 weeks
Procedural effectiveness outcomes (successful closure rate at discharge):
Negative bubble study or residual shunt \<2mm
Time frame: Discharge, 24 weeks
Patient-reported outcomes (QoL):
Quality of life (QoL) using the EuroQoL (EQ-5D-5L™) at baseline, 6 weeks, 24 weeks
Time frame: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (healthcare utilization):
Healthcare utilization (ED admission, physician visit, etc) at 6 and 24 weeks
Time frame: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (SF-12):
Quality of life (QoL) using the SF-12 questionnaire at baseline, 6 weeks, 24 weeks
Time frame: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (HeartQOL):
Quality of life (QoL) using the HeartQOL questionnaire at baseline, 6 weeks, 24 weeks
Time frame: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (satisfaction with device):
Satisfaction with the use of CardioSTAT and KardiaMobile devices using a Likert scale at 24 weeks
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Health Network, Toronto