NCT06014814已完成不适用
Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study
Liverpool Heart and Chest Hospital NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number and Percentage of Patients Converting to General Anaesthesia in the Conscious Sedation Arm
研究概览
简要总结
Prospective case-control study comparing pulsed field ablation for atrial fibrillation under mild conscious sedation vs standard of care (general anaesthesia).
详细描述
This study will prospectively assess 40 patients (20 per arm). Those in the general anaesthesia arm will undergo routine clinical practice. Those in the mild conscious sedation arm will undergo pulsed field ablation with intravenous sedation but without general anaesthesia, though conversion to general anaesthesia is allowed if the patient does not tolerate the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients clinically referred for and undergoing catheter ablation of atrial fibrillation using pulsed field ablation
排除标准
- •Inability to provide informed consent
结局指标
主要结局
Number and Percentage of Patients Converting to General Anaesthesia in the Conscious Sedation Arm
时间窗: Intraprocedural
Requirement for conversion to general anaesthesia from mild conscious sedation
次要结局
- Patient experience (Pain; Relative)(Intraprocedural)
- Patient experience (Discomfort; Relative)(Intraprocedural)
- Patient experience (Anxiety; Relative)(Intraprocedural)
- Patient experience (Pain; Absolute)(Intraprocedural)
- Patient experience (Discomfort; Absolute)(Intraprocedural)
- Patient experience (Anxiety; Absolute)(Intraprocedural)
- Post-operative discomfort (Visual analogue score)(Immediately after the procedure)
- Friends and family test(Immediately after the procedure)
- Acute procedural success(Immediately after the procedure)
- Procedure Duration(During procedure)
- Left atrial dwell time(During procedure)
- Fluoroscopy Duration(During procedure)
- Ablation Duration(During procedure)
- Sedative and anaesthetic drug doses(During procedure)
- Acute Procedural Complications(Immediately after the procedure)
- Same-day discharge rates(24 hours)
研究者
研究点 (1)
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