Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
研究概览
简要总结
Mesh-type flexible tip (MFT) catheter is developed to generate bigger radiofrequency (RF) lesion, and contract force (CF) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (AFCA).
The investigators compared clinical outcome of AFCA conducted by MFT catheter and CF catheter in prospective randomized manner.
The investigators prospectively assigned 230 patients with AF in a 1:1 ratio to ablation by MFT catheter (FlexAbility™, Abbott Inc. USA) and CF catheter (TactiCath™, Abbott Inc. USA). The primary end point was AF recurrence after single procedure, and the secondary end point was response to antiarrhythmic drugs.
详细描述
A. Study design
- Prospective randomization (FlexAbility group vs. TactiCath group )
- Target number of subjects: 360 (180 per group)
- Rhythm follow-up : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate.
B. Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 2 weeks, 2 months, and thereafter every 6-month.
- Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Appropriate indiction for AF catheter ablation (20~80 years old)
- •Echocardiographically measured left atrial size < 55mm
- •Anticoagulation eligible patients
排除标准
- •AF associated with significant cardiac anomaly, structural heart disease affecting hemodynamics
- •Ineligible to CT imaging due to significant renal disease
- •Prior history of AF catheter ablation or cardiac surgery
- •Active internal bleeding
- •Anticoagulation ineligible patients
- •Valvular AF
- •Life expectancy < 1year
- •Drug or alcohol addicted patients
- •Other unacceptable patients for clinical trial determined by investigators
结局指标
主要结局
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
时间窗: 24 months after the procedure
procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month
时间窗: 1 month after the procedure
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
时间窗: 24 months after the procedure
次要结局
- procedure time(intraoperative)
- RF energy delivery time(within 30 minutes after the procedure)
- post-procedural cardioversion rate(24 months after the procedure)
- post-procedural readmission rate(24 months after the procedure)
- volume of irrigated saline infusion(within 30 minutes after the procedure)