Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and outcome assessors will be blinded to the device they receive. Healthcare providers or site coordinators cannot be blinded due to clear differences between devices.
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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.
结局指标
主要结局
Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE)
时间窗: 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.
次要结局
- Subclinical AF (SCAF) burden (number of episodes):(14 days)
- Subclinical AF (SCAF) burden (total time):(14 days)
- Subclinical AF (SCAF) burden (percent time):(14 days)
- Procedural effectiveness outcomes (acute technical success rate at discharge)(Discharge, 24 weeks)
- Patient-reported outcomes (QoL):(Baseline, 6 weeks, 24 weeks)
- Subclinical AF (SCAF) burden (days):(14 days)
- Patient-reported outcomes (HeartQOL):(Baseline, 6 weeks, 24 weeks)
- Procedural effectiveness outcomes (successful closure rate at discharge):(Discharge, 24 weeks)
- Patient-reported outcomes (healthcare utilization):(Baseline, 6 weeks, 24 weeks)
- Patient-reported outcomes (SF-12):(Baseline, 6 weeks, 24 weeks)
- Patient-reported outcomes (satisfaction with device):(24 weeks)
研究者
Eric Horlick
Interventional and Congenital Cardiologist
University Health Network, Toronto