Atrial Septal DefectTrio-ASDNCT04291898
Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
A study testing AMPLATZER™ Septal Occluder., Occlutech Figulla Flex II® and GORE® CARDIOFORM ASD Occluder in people with Atrial Septal Defect, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- AMPLATZER™ Septal Occluder., Occlutech Figulla Flex II® and GORE® CARDIOFORM ASD Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesCanada
- Study dates
- 23 Nov 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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,
Show all 19Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Not yet recruiting
Institut de Cardiologie de Montreal (MHI)
Montreal, Quebec, H1T 1C8
Reda Ibrahim, MD
Anita Asgar, MD
- Not yet recruiting
Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval
Québec, Quebec, G1V 4G5
Josep R Cabau, MD
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Lusine Abrahamyan, MD, PhD, lusine.abrahamyan@utoronto.ca
Eric Horlick, MD
- Not yet recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Ronald Carere, MD
Mounir Riahi, MD
About this study
Official title: Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)
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.
Read the 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.
- Conditions
- Atrial Septal Defect
- Being tested
- AMPLATZER™ Septal Occluder., Occlutech Figulla Flex II®, GORE® CARDIOFORM ASD Occluder
- Keywords
- Transcatheter, Closure, Percutaneous, Atrial Septal Defect
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER™ Septal Occluder.Device
Implantation of the AMPLATZER™ Septal Occluder in the ASD.
Occlutech Figulla Flex II®Device
Implantation of the Occlutech Figulla Flex II® in the ASD.
GORE® CARDIOFORM ASD OccluderDevice
Implantation of the GORE® CARDIOFORM ASD Occluder or GORE® CARDIOFORM Septal Occluder in the ASD.
| Study group | Role | What they receive |
|---|---|---|
| Device: ASO | Active comparator | Participants implanted with the AMPLATZER™ Septal Occluder (ASO) Receives: Device: AMPLATZER™ Septal Occluder. |
| Device: FSO | Active comparator | Participants implanted with the Occlutech Figulla Flex II® (FSO). Receives: Device: Occlutech Figulla Flex II® |
| Device: GSO/GAO | Active comparator | Participants implanted with the GORE® CARDIOFORM ASD Occluder (GSO/GAO) Receives: Device: GORE® CARDIOFORM ASD Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (11)
Subclinical AF (SCAF) burden (days):
Days with >6 min of AF detected on CardioSTAT monitor during 14 days
Measured: 14 days
Subclinical AF (SCAF) burden (number of episodes):
Number of episodes with >6 min of AF detected on CardioSTAT monitor during 14 days
Measured: 14 days
Subclinical AF (SCAF) burden (total time):
Total time in AF during 14 days
Measured: 14 days
Subclinical AF (SCAF) burden (percent time):
Percent time in AF during 14 days
Measured: 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
Measured: Discharge, 24 weeks
Procedural effectiveness outcomes (successful closure rate at discharge):
Negative bubble study or residual shunt <2mm
Measured: Discharge, 24 weeks
Patient-reported outcomes (QoL):
Quality of life (QoL) using the EuroQoL (EQ-5D-5L™) at baseline, 6 weeks, 24 weeks
Measured: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (healthcare utilization):
Healthcare utilization (ED admission, physician visit, etc) at 6 and 24 weeks
Measured: 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
Measured: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (HeartQOL):
Quality of life (QoL) using the HeartQOL questionnaire at baseline, 6 weeks, 24 weeks
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start23 Nov 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Heart Institute, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, St. Paul's Hospital, Canada
- Responsible party
- Principal investigator, Eric Horlick, University Health Network, Toronto
- Investigators
- Eric Horlick, MD, Principal investigator, University Health Network, Peter Munk Cardiac CentreLusine Abrahamyan, MD, PhD, Principal investigator, University Health Network, Theta Collaborative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291898
- Sponsor's protocol ID
- 21-6095
- Other IDs
- TrioASD
- Acronym
- Trio-ASD
- Status last verified
- Apr 2023
- First submitted
- 26 Feb 2020
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)
- ClinicalTrials.gov ID
- NCT04291898
- Acronym / sponsor ID
- Trio-ASD / 21-6095
- Conditions
- Atrial Septal Defect
- Keywords
- Transcatheter, Closure, Percutaneous, Atrial Septal Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Montreal Heart Institute, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, St. Paul's Hospital, Canada
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Device: ASO | Active comparator | Device: AMPLATZER™ Septal Occluder.Participants implanted with the AMPLATZER™ Septal Occluder (ASO) |
| Device: FSO | Active comparator | Device: Occlutech Figulla Flex II®Participants implanted with the Occlutech Figulla Flex II® (FSO). |
| Device: GSO/GAO | Active comparator | Device: GORE® CARDIOFORM ASD OccluderParticipants implanted with the GORE® CARDIOFORM ASD Occluder (GSO/GAO) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMPLATZER™ Septal Occluder.Implantation of the AMPLATZER™ Septal Occluder in the ASD. | Device | Device: ASO |
| Occlutech Figulla Flex II®Implantation of the Occlutech Figulla Flex II® in the ASD. | Device | Device: FSO |
| GORE® CARDIOFORM ASD OccluderImplantation of the GORE® CARDIOFORM ASD Occluder or GORE® CARDIOFORM Septal Occluder in the ASD. | Device | Device: GSO/GAO |
Primary outcome
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.
11 secondary outcomes
Subclinical AF (SCAF) burden (days):
Time frame: 14 days
Subclinical AF (SCAF) burden (number of episodes):
Time frame: 14 days
Subclinical AF (SCAF) burden (total time):
Time frame: 14 days
Subclinical AF (SCAF) burden (percent time):
Time frame: 14 days
Procedural effectiveness outcomes (acute technical success rate at discharge)
Time frame: Discharge, 24 weeks
Procedural effectiveness outcomes (successful closure rate at discharge):
Time frame: Discharge, 24 weeks
Patient-reported outcomes (QoL):
Time frame: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (healthcare utilization):
Time frame: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (SF-12):
Time frame: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (HeartQOL):
Time frame: Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (satisfaction with device):
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Horlick, MD principal investigator
University Health Network, Peter Munk Cardiac Centre
Lusine Abrahamyan, MD, PhD principal investigator
University Health Network, Theta Collaborative
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMPLATZER™ Septal Occluder., Occlutech Figulla Flex II® and GORE® CARDIOFORM ASD Occluder in people with Atrial Septal Defect, run by University Health Network, Toronto at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lusine Abrahamyan, MD, PhD (416-340-4800, lusine.abrahamyan@theta.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.