Comparison of Comprehensive CT-guided Versus Traditonal Echo-fluoroscopy-guided Strategy in the Implantation of the LAmbre Left Atrial Appendage Occlusion, a Prospective, Multi-center and Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- the rate of success at first device selected
研究概览
简要总结
Percutaneous left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with nonvalvular atrial fibrillation (AF). Transesophageal echocardiography (TEE) and fluoroscopy were used to measure the maximal diameters of LAA. However, the LAA maximal diameters measured on Two dimensional (2D) views could be limited due to the morphology of LAA varies with each individua. Three dimension computed tomography angiography technology (3D-CTA) is based on cardiac computed tomography angiography (CCTA). The 3D-CTA technology provides an innovative measuring method of LAA to guide the selection of device size, and the best fluoroscopy view to implant device. This measuring method and guideline have never been reported and its role in LAAO is uncertain
详细描述
The PERIVISION-LAAO study will be a prospective, multi-center and randomized trial designed to investigate the effect and safety of perimeter obtained by 3D-CTA versus diameter obtained by traditional echo-fluoroscopy in guidance of device size selection in the procedure of LAAO. It will enroll 310 patients with nonvalvular atrial fibrillation (AF) who will be randomized at 1:1 ratio into the perimeter guidance group or diameter guidance group. The major effect endpoint will be the success at first device selected in procedure, and the major safety outcome will be the incidence of pericardial effusion during the procedure and the follow-up period of 2 months after the procedure.
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
- •Clinical diagnosis of atrial fibrillation Disease
- •Age >18years
- •CHA2DS2-VASc scores ≥ 2
- •And at least one of the following indications: (a) HAS- BLED scores ≥ 3; (b) intolerance to long-term OAC; (c) stroke, TIA or thromboembolism even under OAC treatment
排除标准
- •GFR <50 mL/min/1.73 m2
- •Thrombus in LA and LAA
结局指标
主要结局
the rate of success at first device selected
时间窗: In the procedure of LAAO
the device selected successfully at first time during LAAO
次要结局
未报告次要终点