Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study

Not Applicable

Recruiting

• Conditions: Atrial Septal Defect
• Interventions: Device: Occlutech Figulla Flex II®; Device: AMPLATZER™ Septal Occluder.; Device: GORE® CARDIOFORM ASD Occluder

• Registration Number: NCT04291898
• Lead Sponsor: University Health Network, Toronto

Brief 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.

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 Timeline

• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Study Start: 2022-11-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device: FSO	Occlutech Figulla Flex II®	Participants implanted with the Occlutech Figulla Flex II® (FSO).
Device: ASO	AMPLATZER™ Septal Occluder.	Participants implanted with the AMPLATZER™ Septal Occluder (ASO)
Device: GSO/GAO	GORE® CARDIOFORM ASD Occluder	Participants implanted with the GORE® CARDIOFORM ASD Occluder (GSO/GAO)

Primary Outcome Measures

Name	Time	Method
Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE)	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.

Secondary Outcome Measures

Name	Time	Method
Subclinical AF (SCAF) burden (number of episodes):	14 days	Number of episodes with \>6 min of AF detected on CardioSTAT monitor during 14 days
Subclinical AF (SCAF) burden (total time):	14 days	Total time in AF during 14 days
Subclinical AF (SCAF) burden (percent time):	14 days	Percent time in AF during 14 days
Procedural effectiveness outcomes (acute technical success rate at discharge)	Discharge, 24 weeks	Successful deployment and retention without major device related complications, stroke, myocardial infarction (MI) or arrhythmia requiring antiarrhythmic drug or cardioversion
Patient-reported outcomes (QoL):	Baseline, 6 weeks, 24 weeks	Quality of life (QoL) using the EuroQoL (EQ-5D-5L™) at baseline, 6 weeks, 24 weeks
Subclinical AF (SCAF) burden (days):	14 days	Days with \>6 min of AF detected on CardioSTAT monitor during 14 days
Patient-reported outcomes (HeartQOL):	Baseline, 6 weeks, 24 weeks	Quality of life (QoL) using the HeartQOL questionnaire at baseline, 6 weeks, 24 weeks
Procedural effectiveness outcomes (successful closure rate at discharge):	Discharge, 24 weeks	Negative bubble study or residual shunt \<2mm
Patient-reported outcomes (healthcare utilization):	Baseline, 6 weeks, 24 weeks	Healthcare utilization (ED admission, physician visit, etc) at 6 and 24 weeks
Patient-reported outcomes (SF-12):	Baseline, 6 weeks, 24 weeks	Quality of life (QoL) using the SF-12 questionnaire at baseline, 6 weeks, 24 weeks
Patient-reported outcomes (satisfaction with device):	24 weeks	Satisfaction with the use of CardioSTAT and KardiaMobile devices using a Likert scale at 24 weeks

Trial Locations

Locations (4)

Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval; 🇨🇦 Québec, Quebec, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Institut de Cardiologie de Montreal (MHI); 🇨🇦 Montréal, Quebec, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada