Influence of Localization of ACT-measurement and Influence of LAA on ACT Among Patients Undergoing Left Atrial Ablation Procedure.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Comparison of mean and median values of ACT measurements from LA und LAA and dependency on anatomic and functional LAA parameters among patients in sinus rhythm.
研究概览
简要总结
Ablation of atrial fibrillation is standard therapy for symptomatic patients or patients with severely reduced systolic left ventricular ejection fraction. Complications of the procedure are ischemic thrombembolic stroke. Therefore periprocedural treatment with heparin is administered to acchieve a therapeutic anticoagulation. The efficacy of anticoagulation is measured by active-clotting time (ACT) which is measured with blood drawn mostly from the V. femoralis.
Despite controlled anticoagulation periprocedural stroke is published with an incidence of up to 2% and asymptomatic cerebral embolization from 2% to 15%.
The ACT-Trial has two aims:
- Analysis of the influence of the localization of blood drawing on the measured ACT: blood from central venous line, from LA and from LAA.
- Dependency of the ACT measured in the blood of the LAA with regard to anatomic und functional LAA-measurements.
Patients will be included scheduled for left atrial ablation procedure and will be divided in two groups: atrial fibrillation at time of procedure and sinus rhythm at time of procedure.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 until 80 years with atrial fibrillation scheduled for left atrial ablation procedure (according to 20216 ESC Guidelines for the management of atrial fibrillation" and/or "2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation"
- •signed informed consent.
- •hemoglobin >10 g/dl in Messungen up to 8 weeks before inclusion.
- •Exclusion criteria:
- •Incompliance or contraindication of oral anticoagulation prior to ablation procedure.
排除标准
- 未提供
结局指标
主要结局
Comparison of mean and median values of ACT measurements from LA und LAA and dependency on anatomic and functional LAA parameters among patients in sinus rhythm.
时间窗: During ablation procedure
Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured at the same time.
次要结局
- Target values of ACT measured in central venous line, LA and LAA among patients with sinus rhythm(During ablation procedure)
- Target values of ACT measured in central venous line, LA and LAA among patients with atrial fibrillation(During ablation procedure)
- Dynamics of ACT values over time from samples taken from central venous line, LA and LAA among patients with sinus rhythm(During ablation procedure)
- Dynamics of ACT values over time from samples taken from central venous line, LA and LAA among patients with atrial fibrillation(During ablation procedure)