- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04291898
Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study (Trio-ASD)
Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)
Study Overview
Status
Conditions
Intervention / Treatment
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 GAO/GSO) to compare the effectiveness and safety outcomes of three different ASD closure devices.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- Not yet recruiting
- St. Paul's Hospital
-
-
Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- Toronto General Hospital
-
-
Quebec
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Montréal, Quebec, Canada, H1T 1C8
- Not yet recruiting
- Institut de Cardiologie de Montreal (MHI)
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Québec, Quebec, Canada, G1V 4G5
- Not yet recruiting
- Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥18 years old referred for percutaneous (secundum) ASD closure with right atrial and ventricular enlargement; and
- clinically significant left-to-tight shunt (Qp:Qs≥1.5:1), or
- evidence of paradoxical embolism (with a TEE defect >10mm),
- written informed consent
Exclusion Criteria:
- TEE/CCT/CMR defect diameter >30mm,
- rim sizes of < 5 mm to the coronary sinus, inferior vena cava rim, an atrioventricular valve, or the right upper pulmonary vein,
- multiple defects,
- complex congenital heart disease requiring surgical repair within 3 years of device placement,
- Eisenmenger-syndrome,
- recent myocardial infarction PCI/CABG < 6 weeks,
- demonstrated intra cardiac thrombi on echocardiography (especially LA or LAA thrombi), or atrial tumor
- known occluded bilateral femoral veins/IVC,
- pulmonary artery systolic pressure more than half the systemic systolic arterial pressure
- recent pelvic venous thrombosis
- serious comorbidity with life expectancy <3 years (e.g., non-skin cancers not in remission, advanced renal failure serum creatinine >160 umol/L)
- patients whose size or condition would cause the patient to be a poor candidate choice for cardiac catheterization (e.g., too small for echocardiographic imaging probe, catheter size, vascular size, active infection, body weight < 8 kg)
- serious infection in < 6 weeks producing bacteremia (e.g. sepsis), active endocarditis, or any other infection that cannot be treated successfully prior to device implantation (patient must have negative blood cultures off antibiotics for 1 week prior to procedure),
- active GI bleed < 6 weeks,
- bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months
- previous stroke in the past 12 months,
- documented chronic atrial fibrillation or >2 episodes of documented paroxysmal atrial fibrillation in the last 12 months,
- pregnancy or breastfeeding, plan to become pregnant within the next 6 months, not using an effective method of birth control in premenopausal women,
- documented nickel/titanium allergy, or intolerance to contrast agents.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Device: ASO
Participants implanted with the AMPLATZER™ Septal Occluder (ASO)
|
Implantation of the AMPLATZER™ Septal Occluder in the ASD.
|
Active Comparator: Device: FSO
Participants implanted with the Occlutech Figulla Flex II® (FSO).
|
Implantation of the Occlutech Figulla Flex II® in the ASD.
|
Active Comparator: Device: GSO/GAO
Participants implanted with the GORE® CARDIOFORM ASD Occluder (GSO/GAO)
|
Implantation of the GORE® CARDIOFORM ASD Occluder or GORE® CARDIOFORM Septal Occluder in the ASD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE)
Time Frame: 24 weeks
|
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.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subclinical AF (SCAF) burden (days):
Time Frame: 14 days
|
Days with >6 min of AF detected on CardioSTAT monitor during 14 days
|
14 days
|
Subclinical AF (SCAF) burden (number of episodes):
Time Frame: 14 days
|
Number of episodes with >6 min of AF detected on CardioSTAT monitor during 14 days
|
14 days
|
Subclinical AF (SCAF) burden (total time):
Time Frame: 14 days
|
Total time in AF during 14 days
|
14 days
|
Subclinical AF (SCAF) burden (percent time):
Time Frame: 14 days
|
Percent time in AF during 14 days
|
14 days
|
Procedural effectiveness outcomes (acute technical success rate at discharge)
Time Frame: Discharge, 24 weeks
|
Successful deployment and retention without major device related complications, stroke, myocardial infarction (MI) or arrhythmia requiring antiarrhythmic drug or cardioversion
|
Discharge, 24 weeks
|
Procedural effectiveness outcomes (successful closure rate at discharge):
Time Frame: Discharge, 24 weeks
|
Negative bubble study or residual shunt <2mm
|
Discharge, 24 weeks
|
Patient-reported outcomes (QoL):
Time Frame: Baseline, 6 weeks, 24 weeks
|
Quality of life (QoL) using the EuroQoL (EQ-5D-5L™) at baseline, 6 weeks, 24 weeks
|
Baseline, 6 weeks, 24 weeks
|
Patient-reported outcomes (healthcare utilization):
Time Frame: Baseline, 6 weeks, 24 weeks
|
Healthcare utilization (ED admission, physician visit, etc) at 6 and 24 weeks
|
Baseline, 6 weeks, 24 weeks
|
Patient-reported outcomes (SF-12):
Time Frame: Baseline, 6 weeks, 24 weeks
|
Quality of life (QoL) using the SF-12 questionnaire at baseline, 6 weeks, 24 weeks
|
Baseline, 6 weeks, 24 weeks
|
Patient-reported outcomes (HeartQOL):
Time Frame: Baseline, 6 weeks, 24 weeks
|
Quality of life (QoL) using the HeartQOL questionnaire at baseline, 6 weeks, 24 weeks
|
Baseline, 6 weeks, 24 weeks
|
Patient-reported outcomes (satisfaction with device):
Time Frame: 24 weeks
|
Satisfaction with the use of CardioSTAT and KardiaMobile devices using a Likert scale at 24 weeks
|
24 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-6095
- TrioASD (Other Identifier: UHN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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