LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism
研究概览
简要总结
The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.
详细描述
Percutaneous left atrial appendage closure (LAAC) has established itself in clinical practice as a safe and efficient therapeutic option for atrial fibrillation patients with a relative/absolute contraindication to oral anticoagulation. The purpose of this observational study is to prospectively collect procedural and follow-up data of all patients submitted to a clinically indicate LAAC in order to assess the impact of patient characteristics, procedural technique (imaging used to guide/plan procedure, device implanted, post-procedural drug regimens, etc.) on procedural safety and efficacy. The endpoints will be assessed by means of clinical follow-up at 1-3-5 years after LAAC and imaging exams (TEE at1-3 months, CCTA at 1-13months).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent to participate in the study
- •Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are planned for an elective LAA-closure
- •Anatomic characteristics allow placement of a CE marked device, dedicated for LAAC
排除标准
- •None. Considering the nature of the project, which is to prospectively collect information on all patients treated with LAAC in our center, we will only exclude patients unwilling to sign the informed consent.
结局指标
主要结局
Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism
时间窗: 1 to 5 Years
Protection from cardiovascular death, ischemic stroke and systemic embolism
Feasibility Endpoint - Total procedure time (min)
时间窗: During the LAAC Procedure (≃ 60 minutes )
Total procedure time (min)
Feasibility Endpoint - dose of contrast medium (ml)
时间窗: During the LAAC Procedure (≃ 60 minutes )
dose of contrast medium (ml)
Feasibility Endpoint - dose of x-ray (cGy.cm2)
时间窗: During the LAAC Procedure (≃ 60 minutes )
dose of x-ray (cGy.cm2)
Feasibility Endpoint - number of device implantation attempt during the procedure (number)
时间窗: During the LAAC Procedure (≃ 60 minutes )
number of device implantation attempt during the procedure (number)
Primary Safety Endpoint
时间窗: 7 days
Composite of Death, cerebrovascular events, cardiac tamponade, need for urgent surgery, need for cardiopulmonary resuscitation, device embolization, non vascular access-related major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) or acute kidney injury.
Secondary Efficacy Endpoint - Incidence of technical success
时间窗: 7 days to 13 months
Technical success defined as adequate LAA ostium closure (without residual PDL\>5mm or patent lobes) in absence of device complications (according to the Munich Consensus Document)
Feasibility Endpoint - number of device change during the procedure (number)
时间窗: During the LAAC Procedure (≃ 60 minutes )
number of device change during the procedure (number)
Net Clinical Benefit Endpoint
时间窗: 1 to 5 years
Composite of death, stroke, systemic embolism, pulmonary embolism, myocardial infarction, and major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) not procedure-related.
LAA patency
时间窗: 45 days to 13 months
LAA patency and its subtypes as evaluated by TEE and/or CCTA
Device related thrombus
时间窗: 45 days to 13months
Device related thrombus detected by TEE and /or CCTA on the atrial surface of device
次要结局
- Maximal Hypoattentuated Thickening on atrial surface of device(45 days - 3 months - 13months)
- Percentage of atrial surface of device covered(45 days - 3 months - 13months)
- Percentage of device length coverage(45 days - 3 months - 13months)