Clinical trial NCT04291898: Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
Official title: Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Septal Defect
Keywords: Transcatheter
Closure
Percutaneous
Atrial Septal Defect
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Montreal Heart Institute
name: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
name: St. Paul's Hospital, Canada
First posted: 2020-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE)
timeFrame: 24 weeks
Secondary outcomes:
measure: Subclinical AF (SCAF) burden (days):
timeFrame: 14 days
measure: Subclinical AF (SCAF) burden (number of episodes):
timeFrame: 14 days
measure: Subclinical AF (SCAF) burden (total time):
timeFrame: 14 days
measure: Subclinical AF (SCAF) burden (percent time):
timeFrame: 14 days
measure: Procedural effectiveness outcomes (acute technical success rate at discharge)
timeFrame: Discharge, 24 weeks
measure: Procedural effectiveness outcomes (successful closure rate at discharge):
timeFrame: Discharge, 24 weeks
measure: Patient-reported outcomes (QoL):
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Patient-reported outcomes (healthcare utilization):
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Patient-reported outcomes (SF-12):
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Patient-reported outcomes (HeartQOL):
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Patient-reported outcomes (satisfaction with device):
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal (MHI)
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval
state: Quebec
Study officials:
affiliation: University Health Network, Peter Munk Cardiac Centre
name: Eric Horlick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Theta Collaborative
name: Lusine Abrahamyan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: