Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter to Prevent Post-procedural Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- number of paroxysms of atrial fibrillation
研究概览
简要总结
The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum toxin injection for preventing post-procedural atrial fibrillation in patients undergoing the radiofrequency ablation of atrial flutter.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ECG documented paroxysmal or persistent AFL
- •No prior documented history of AF
- •Patient undergoing RFA of AFL.
- •No indication (other than AFL) for continued anticoagulation with warfarin.
- •No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)
排除标准
- •A history of atrial fibrillation
- •Previous AF ablation procedure
- •Congestive heart failure
- •Left Ventricle ejection fraction less than 35%
- •Unwillingness to participate
研究组 & 干预措施
RFA+BT injection
Transseptal puncture is performed by used standard endovascular approach. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
干预措施: radiofrequency ablation (Procedure)
RFA+BT injection
Transseptal puncture is performed by used standard endovascular approach. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
干预措施: Botulinum Toxin Type A injection (Drug)
RFA
Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a flow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).
干预措施: radiofrequency ablation (Procedure)
结局指标
主要结局
number of paroxysms of atrial fibrillation
时间窗: 1 year
次要结局
- serious adverse events(1 year)
- AF burden(1 year)