LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- PDL size after 3 months
研究概览
简要总结
The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation/ atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy.
The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.
详细描述
AMPIRI is an investigator-initiated, prospective, randomized, multi-center, open-label, non-inferiority other clinical investigation. All consecutive patients with non-valvular AF at increased risk for stroke or systemic embolism based on CHA2DS2-VASc score not eligible for long-term oral anticoagulation therapy will qualify for screening. Patients with confirmed eligibility and who have given written informed consent will be randomized in a 1:1 fashion to group A (LAmbre LAAO device) or group B (AMPLATZER Amulet LAAO device). Clinical indication, technique, and timing of LAAO will be at the operator's discretion.
The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is PDL size 3 months after LAAO, as assessed with TOE in patients with non-valvular AF.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and able to give consent
- •Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation/ atrial flutter (AF) at high risk of stroke or systemic embolism defined by CHA2DS2-VASc score ≥ 2 (male) or ≥ 3 (female)
- •Patient not eligible for long-term oral anticoagulation therapy
- •Deemed suitable for percutaneous LAAO
- •Able to comply with the required medication regimen after LAAO device implantation
- •Written informed consent
- •LAA anatomy can accommodate either a LAmbre or AMPLATZER Amulet LAAO device, as per manufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial)
- •For women of childbearing potential, negative pregnancy test and agree to use reliable method of birth control during the study
排除标准
- •Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)
- •LAA is obliterated or surgically ligated
- •Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen
- •Prior atrial septal defect (ASD) repair or implantation of ASD closure device
- •Active endocarditis or other infection producing bacteremia
- •Significant symptomatic carotid artery disease
- •Participation in a concurrent clinical trial, which may confound the results of this trial
- •Patient cannot adhere to or complete the trial protocol for any reason
- •Or any of the following echocardiographic exclusion criteria:
- •Intracardiac thrombus
- •Intracardiac tumor
- •Existing, clinically relevant circumferential pericardial effusion
- •Significant mitral valve stenosis
结局指标
主要结局
PDL size after 3 months
时间窗: three months
Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.
次要结局
- Procedural Duration(at index procedure)
- Device-related complications(at three months)
- All-stroke(during index hospitalization and up to 24 months)
- Device Sucess(at index prozedure)
- Procedural success(at index procedure)
- Large residual peri-device leak size > 5mm(at three months)
- Systemic embolism(during index hospitalization and up to 24 months)
- Procedure-related complications(during index hospitalization)
- Device thrombus(at three months)
- Technical success(during index hospitalization)
- Major bleeding(during index hospitalization)
- All-cause death or cardiovascular death(during index hospitalization and up to 24 months)
- Composite of ischaemic stroke or systemic embolism(during index hospitalization and up to 24 months)