NCT04716270招募中不适用
Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure (AALARA)
Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2021年1月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Incidence of procedure related cardiac Adverse Events (Safety)
研究概览
简要总结
Observational study is to demonstrate a clinically significant reduction of ionizing radiation exposure during transcatheter ablation of supraventricular tachycardias using the EnSite precision mapping system in a real-world clinical setting without compromising efficacy and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female patients ≥ 18 years of age
- •Patient indicated for supraventricular arrhythmias ablation according to the current guidelines
- •Patient is willing to provide written informed consent.
排除标准
- •Patient is pregnant.
- •Contraindications to ionizing radiation exposure
- •Patient's life expectancy is less than 1 year
- •Associated complex congenital heart disease
- •Cardiac implantable electric devices
- •Known pathological venous access to the heart
结局指标
主要结局
Incidence of procedure related cardiac Adverse Events (Safety)
时间窗: 6 months
Cardiac related serious adverse events frequency during and after ablation procedure of supraventricular arrhythmias
Radiation exposure dose
时间窗: The day of performing the procedure
The dose of ionizing radiation exposure in patients undergoing Supraventricular Tachycardia catheter ablation utilizing a non-fluoroscopic EnSite Precision 3D mapping system
次要结局
- Fluoroscopy time(The day of performing the procedure)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic ActivityVentricular TachycardiaNCT04837183Mayo Clinic30
终止
不适用
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and PaceAtrial FibrillationCongestive Heart FailureNCT00356057Biotronik, Inc.153
招募中
不适用
SBRT for Ventricular ArrhythmiaVentricular ArrythmiaNCT06411392Medical University of Graz10
Unknown
4 期
Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual AblationArrhythmiasNCT01834872Instituto de Investigación Sanitaria Gregorio Marañón50
Unknown
不适用
Non-fluoroscopy Ablation of AF/ATAF - Atrial FibrillationAtrial TachycardiaNCT03750435Royal Brompton & Harefield NHS Foundation Trust25