Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation: Q-INDEX Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Time for AF ablation
研究概览
简要总结
This study aims to investigate the effect of reducing ablation time for a hybrid approach of vHPSD and AI-guided ablation using the QDOT Micro catheter in PVI among patients with PAF.
详细描述
Radiofrequency catheter ablation has become a cornerstone strategy for the rhythm control of AF. During the last decade, catheter technology has revolutionized and, accordingly, clinical outcomes after the ablation and procedural efficacy have been improved.
In recent years, the use of the CLOSE protocol employing contiguous, closely spaced applications and targeted ablation index (AI) values has translated into robust acute and long-term success rates for PVI, typically with the power delivery of up to 35 W, and more recently with 40 to 50 W, in power and temperature-controlled mode.
Contiguous ablation using very high-power, short-duration ablation at 90 W over 4 seconds is expected to shorten procedure time. However, changes in lesion geometry and the altered impact of catheter stability on lesion quality may influence procedural efficiency, safety, and effectiveness.
The Q-FFICIENCY trial showed that the vHPSD (90 W, 4 sec), temperature-controlled radiofrequency ablation (25/50 W) has comparable efficacy to conventional-power temperature-controlled ablation.
However, the efficacy of vHPSD ablation may depend on PV thickness due to its lesion characteristics. Therefore, AI-guided ablation may have merits over vHPSD ablation in thickened PV segments. According to the POWER PLUS trial, the proportion of 1st-pass PVI with vHPSD ablation was numerically lower than that of the conventional ablation, although there was marginal significance; 83.9% vs. 90.0%, p-value =0.085.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing PVI for PAF
排除标准
- •Aged less than 19 years
- •Patients with persistent AF
- •Patients with previous ablation or surgery for AF
- •Patients with intracardiac thrombus or thromboembolic events within the previous 90 days
- •Patients with cardiac surgery or acute coronary syndrome within the previous 90 days
- •Patients with contraindication(s) for using oral anticoagulants
- •Patients with LA anteroposterior diameter of more than 55 mm
- •Patients with left ventricular ejection fraction less than 35%
- •Pregnants or those who plan to become pregnant during the study
- •Life expectancy less than a year
研究组 & 干预措施
vHPSD ablation only for PVI
Pulmonary vein encirclement is achieved using contiguous applications of very high power and short duration (90 W over 4 seconds). The inter-lesion distance is set at 3-4mm for the roofs and anterior segments, and 5-6mm for other segments. If the esophageal temperature rises > 38 for segments near the esophagus, encirclement will be applied at 25 W for 15 seconds.
干预措施: QDOT MicroTM catheter (Device)
vHPSD and AI-guided ablation for PVI
At the anterior segments, pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500, and an inter-lesion distance of 4mm).
In the other segments, pulmonary vein encirclement is achieved through contiguous applications using very high-power and short-duration techniques (90 W over 4 seconds, inter-lesion distance of 3-4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds).
干预措施: QDOT MicroTM catheter (Device)
vHPSD and AI-guided ablation for PVI
At the anterior segments, pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500, and an inter-lesion distance of 4mm).
In the other segments, pulmonary vein encirclement is achieved through contiguous applications using very high-power and short-duration techniques (90 W over 4 seconds, inter-lesion distance of 3-4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds).
干预措施: AI-guided ablation only for PVI (Device)
AI-guided ablation only for PVI
Pulmonary vein encirclement is achieved through contiguous applications using AI-guided ablation (40-50 W, AI target 500 for anterior segments and 400 for other segments, with an inter-lesion distance of 4mm; if the segments are near the esophagus, encirclement will be applied at 25 W for 15 seconds)
干预措施: AI-guided ablation only for PVI (Device)
结局指标
主要结局
Time for AF ablation
时间窗: up to 12 months
Including total PVI time, total ablation time, fluoroscopic time, and total procedure time.
次要结局
- Acute PV reconnection rate(up to 12 months)
- The segment of residual PV potential(up to 12 months)
- The segment of early reconnection(up to 12 months)
- 1-year AF recurrence(up to 12 months)
- 30-day complication associated with procedure(up to 12 months)