Using Deep Sedation Vs. Conscious Sedation in Catheter Ablation in Patients with Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,334
- 试验地点
- 16
- 主要终点
- Rhythm outcomes
研究概览
简要总结
The current practice of anesthesia for atrial fibrillation catheter ablation （CA） procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. Currently, a considerable number of procedures have been done using conscious sedation. Previous studies explored the benefits obtained from the employment of deep sedation in AF ablation procedures, mainly focused on pain reduction and intra-procedural safety. However, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients/ablators/lab staff have yet not to be thoroughly studied. We plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent AF in multiple prospective, i.e., quantified intraprocedural patients / physicians / lab staffs / mapper clinical specialist experiences, and the procedure safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The present trial utilized a centralized randomization system (IWRS) to facilitate the competitive enrollment of study participants and treatment randomization grouping. The investigator (anesthesiologist) carries out the given treatment according to the grouping information of the study participants. Throughout the course of the study, the treatment groups were kept blind to the researchers, with the exception of the anesthesiologist, the sponsor, and the study participants.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure
排除标准
- •has received CA procedure for AF or atrial septal defect repair before enrollment
- •left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;
- •eGFR<30mL/min/1.73㎡
- •a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack [TIA])
- •acute or severe systemic infection
- •intolerant to sedation or with a history suggestive of sleep apnea
- •BMI > 35 kg/㎡
- •has contraindications to procedural sedation or refused to participate in this trial
- •Congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio (INR) > 1.5 or partial activated prothrombin time (APTT) prolonged by ≥ 10 seconds, or plasma prothrombin time (PT) prolonged by ≥ 3 seconds, or fibrinogen (Fib) ≤ 1.5 g/L), or active bleeding
- •pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period
- •life expectancy < 12 months
- •those who have participated in other clinical drug trials within 3 months prior to enrollment
- •those who are known to be allergic to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc.
- •those who, in the judgment of the investigator, are not suitable for this clinical study (e.g., not in line with the treatment that the research participants the treatment, research participant compliance, etc.).
结局指标
主要结局
Rhythm outcomes
时间窗: 4-12month post-ablation
The primary effectiveness endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month (9 months) after the procedure without taking I/III AADs. Patients who had to redo ablation or failed to discontinue I/III AADs after the blanking period are considered as primary endpoint
次要结局
- Score of patients' intraprocedural experiences(during the CA procedure)
- Score of ablators', staffs',nurse's intraprocedural experiences(during the CA procedure)
- respiratory system safety outcome(From the start of sedation to the end of the procedure)
- Rate of re-ablation acceptances(4-12month post-ablation)
- Procedure time(during the CA procedure)
- The dosage of painkillers(during the CA procedure)
- the incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway(From the start of sedation to the end of the procedure)