NCT07734194招募中不适用
Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月1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
- 20
- 试验地点
- 1
- 主要终点
- Primary endpoint 1
研究概览
简要总结
This prospective single-arm study will evaluate whether mild conscious sedation using remimazolam with fentanyl is a feasible alternative to deeper sedation or general anaesthesia during FARAPULSETM pulsed-field ablation for paroxysmal atrial fibrillation, with careful periprocedural monitoring and assessment of both sedation-related safety outcomes and patient-reported procedural experience.
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
- •Age above 18y Paroxysmal or persistent AF written agreement with inclusion to the study
排除标准
- •BMI > 35kg/m2 EF of the left ventricle < 40% OSA syndrome on therapy anticipated difficult airway severe COPD significant valvulopathy (3/4 or more) symptomatic heart failure irrespective of ejection fraction severe pulmonary hypertension benzodiazepine drugs medication (or other sedative drugs at the discretion of the anesthesiologist) myasthenia gravis
结局指标
主要结局
Primary endpoint 1
时间窗: during the procedure
The primary endpoint will be defined as the need for conversion to general anaesthesia or to deep analgesia (by adding another sedative agent).
次要结局
未报告次要终点
研究者
研究点 (1)
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