Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of primary adverse events related to the ablation procedure
研究概览
简要总结
Pulmonary vein isolation is the main treatment of paroxysmal and persistent atrial fibrillation.
The aim of our study is to prospectively compare the efficacy and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions
详细描述
Pulmonary vein isolation (PVI) is the main treatment of paroxysmal and persistant atrial fibrillation.
PVI is achieved by point-by-point radiofrequency ablation that creates flexible lesion set within targeted area.
PVI using standard ablation catheter with limited power (50W) have been described in case series with favorable efficacy and safety.
QDOTMicro™ is a radiofrequency ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution.
QDOT Micro™ provides several options regarding radiofrequency administration :
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 or over
- •First atrial fibrillation ablation
- •Paroxysmal atrial fibillation defined as atrial fibrillation lasting less than 48 hours
- •Early atrial fibrillation defined as atrial fibrillation lastiing between 7 days and 3 months
- •At least one episode of atrial fibrillation in the year preceding study entry
- •Patient affiliated to a health insurance
排除标准
- •History of atrial fibrillation ablation (surgery or catheter)
- •Documented left atrial thrombus
- •Left atrial (LA) diameter > 60mm / LA area > 35cm2 / Left atrial volulme index (LAVI) > 45ml/m2
- •N/STEMI replacement or angioplasty or valve within 3 months prior to registration
- •Any contraindication mentioned in the instructions for use of the QDOT MICRO™ bidirectional navigation catheter
- •Patient unable to understand study information
- •Patient deprived of liberty by judicial or administrative decision
研究组 & 干预措施
Q-MODE
Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W.
干预措施: Q-MODE : radiofrequency ablation up to 50W (Procedure)
Q-MODE+
Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W.
干预措施: Q-MODE+ : radiofrequency up to 90W (Procedure)
Hybride Q-MODE/Q-MODE+
A combination of the two ablation methods.
干预措施: Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part (Procedure)
结局指标
主要结局
Incidence of primary adverse events related to the ablation procedure
时间窗: 7 days after ablation
Incidence of primary adverse events within 7 days after ablation in the 3 arms
Acute procedural success
时间窗: At the end of the ablation procedure
Acute procedural success is defined as electrical isolation of all pulmonary veins
次要结局
- Use of another catheter(At the end of the ablation procedure)
- Time spent in operating room(At the end of the ablation procedure)
- Skin-to-skin time(At the end of the ablation procedure)
- Glove-to-glove time(At the end of the ablation procedure)
- Mapping time(At the end of the ablation procedure)
- Total ablation time(At the end of the ablation procedure)
- Left vein ablation time(At the end of the ablation procedure)
- Right vein ablation time(At the end of the ablation procedure)
- Number of radiofrequency applications(At the end of the ablation procedure)
- Number of vHPSD radiofrequency applications(At the end of the ablation procedure)
- Number of HPSD radiofrequency applications(At the end of the ablation procedure)
- Temperature(At the end of the ablation procedure)
- Power(At the end of the ablation procedure)
- Contact force(At the end of the ablation procedure)
- Impedance(At the end of the ablation procedure)
- Incidence of serious adverse event(within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure)
- Rate of additional lesions(At the end of the ablation procedure)
- Location of additional lesions(At the end of the ablation procedure)