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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
St. Paul's Hospital
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGToronto General Hospital
Toronto, Ontario, Canada
RECRUITINGInstitut de Cardiologie de Montreal (MHI)
Montreal, Quebec, Canada
NOT_YET_RECRUITINGComposite 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
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Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval
Québec, Quebec, Canada
NOT_YET_RECRUITINGTime 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