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)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Septal Defect
• Intervention / Treatment: Device: AMPLATZER™ Septal Occluder.; Device: Occlutech Figulla Flex II®; Device: GORE® CARDIOFORM ASD Occluder

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Not yet recruiting
      • St. Paul's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Toronto General Hospital
  • Quebec
    • Montréal, Quebec, Canada, H1T 1C8
      • Not yet recruiting
      • Institut de Cardiologie de Montreal (MHI)
    • 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: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Device: ASO; Participants implanted with the AMPLATZER™ Septal Occluder (ASO)	Device: AMPLATZER™ Septal Occluder.; Implantation of the AMPLATZER™ Septal Occluder in the ASD.
Active Comparator: Device: FSO; Participants implanted with the Occlutech Figulla Flex II® (FSO).	Device: Occlutech Figulla Flex II®; 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)	Device: GORE® CARDIOFORM ASD Occluder; 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)	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):	Days with >6 min of AF detected on CardioSTAT monitor during 14 days	14 days
Subclinical AF (SCAF) burden (number of episodes):	Number of episodes with >6 min of AF detected on CardioSTAT monitor during 14 days	14 days
Subclinical AF (SCAF) burden (total time):	Total time in AF during 14 days	14 days
Subclinical AF (SCAF) burden (percent time):	Percent time in AF during 14 days	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	Discharge, 24 weeks
Procedural effectiveness outcomes (successful closure rate at discharge):	Negative bubble study or residual shunt <2mm	Discharge, 24 weeks
Patient-reported outcomes (QoL):	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):	Healthcare utilization (ED admission, physician visit, etc) at 6 and 24 weeks	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	Baseline, 6 weeks, 24 weeks
Patient-reported outcomes (HeartQOL):	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):	Satisfaction with the use of CardioSTAT and KardiaMobile devices using a Likert scale at 24 weeks	24 weeks

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: St. Paul's Hospital, Canada; Montreal Heart Institute; Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Septal Defect; Percutaneous; Transcatheter; Closure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial
• Other Study ID Numbers: 21-6095; TrioASD (Other Identifier: UHN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No