Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure: the CALAMBRE Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- EFFICACY: Device success
研究概览
简要总结
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.
详细描述
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion according to the Munich consensus document will be randomized to left atrial appendage closure with either the Amplatzer Amulet™ or the LAmbre™ device. The study is designed to compare the efficacy and safety of both devices regarding successful implantation, effective appendage closure, and clinical outcomes at follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(MUST MEET ALL INCLUSION CRITERIA)
- •Patient with aged ≥18 years AND;
- •Patient have non-valvular atrial (NVAF) with a CHA2DS2-VASc score ≥2, and presented at least one high-bleeding-risk criterion according to the Munich consensus document AND;
- •Patient are required to undergo preprocedural TEE / CCTA to confirm the absence of LAA thrombus and to ensure that LAA anatomy is suitable for closure with either device.
- •Patient who has been informed of the characteristics of the study and has provided written informed consent..
排除标准
- •(MUST NOT MEET ANY EXCLUSION CRITERIA)
- •Patient life expectancy <1 year (terminal illness).
- •Patient with requirement for oral anticoagulation therapy for any indication other than non-valvular atrial fibrillation.
- •Patient with prior surgical ligation or obliteration of the left atrial appendage.
- •Patient with history of allergic reaction or intolerance to any material used in the study devices or to any of the antithrombotic agents required post-procedure.
- •Patient with active systemic infection.
- •Patient with concurrent participation in another investigational study that may affect study results.
- •Patient with inability or unwillingness to comply with the study protocol or follow-up requirements.
- •Patient pregnant or breastfeeding women.
结局指标
主要结局
EFFICACY: Device success
时间窗: 3 months
Percentage Device success defined as: Successful deployment and stable implantation of the assigned device within the left atrial appendage during the index procedure and no crossover to the alternative device and effective closure of the appendage with a residual leak ≤5 mm as assessed by TEE(Transesophageal Echocardiography) or CCTA (Cardiac Computed Tomography Angiography) at 90 days.
次要结局
- EFFICACY: Residual leak(3 months)
- SAFETY: MACE(3 months)
- SAFETY: Clinical success(3 months)
- SAFETY: Procedure-related complications(7 days)
- EFFICACY: Residual leak(12 months)
- SAFETY: MACE(12 months)
- SAFETY:Device-related thrombus (DRT)(3 months)