Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study (REDUCE-TE Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 14
- 主要终点
- Thromboembolic lesions
研究概览
简要总结
The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Electrocardiographically documented, symptomatic paroxysmal AF.
- •Patients with indication for left atrial ablation of AF according to ESC guidelines for the management of atrial fibrillation.
- •Anticoagulation according to clinical routine using coumarin derivates with target INR between 2.0 and 3.0 at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
- •Geographically stable for the duration of the study.
- •Willingness and ability to perform written informed consent
排除标准
- •Long standing persistent or persistent AF
- •CHA2DS2-VASc score ≥ 5
- •Prior ischemic stroke or Transient Ischemic Attack
- •Previous Pulmonary Vein ablation
- •Contraindication for anticoagulation therapy
- •Contraindication for Diffusion-Weighted MRI
- •Claustrophobia
- •Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE, if TEE not possible)
- •Implanted cardiovascular device, including but not limited to an atrial or ventricular pacemaker or defibrillator leads, artificial valves, stents, septal or LAA occluders
- •Acute coronary syndrome < 3 months prior to scheduled ablation
- •Moderate to severe valvular heart disease
- •LA size > 55 mm (confirming echo at maximum 3 months old)
- •Patients with non-controlled heart failure or patients with current and recent (< 1 month prior to ablation) heart failure
- •Ejection fraction < 35% (confirming echo at maximum 3 months old)
- •Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion)
- •Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
- •Any limitation to contractual capability
- •Simultaneous participation in another study
- •Age < 18 years
研究组 & 干预措施
All patients
All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing
干预措施: Cerebral Diffusion-Weighted Magnetic Resonance Imaging (Device)
All patients
All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing
干预措施: Transesophageal Echocardiography (Device)
All patients
All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing
干预措施: Paperbased neurocognitive testing (Other)
结局指标
主要结局
Thromboembolic lesions
时间窗: 1-3 days
The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI
次要结局
- Neurocognitive status(Baseline, 1-3 days and 3 months)
- Peri-procedural serious adverse events(Within 24 hours after ablation)
- Post-procedural clinical TE events(3 months period)