High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation Using the QDOT MICRO™ Catheter - Q-POWER STUDY
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Procedure duration
研究概览
简要总结
Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, characterized by rapid and disorganized atrial activation leading to an irregular heart rhythm. Pulmonary vein isolation (PVI) ablation is the gold standard for catheter ablation based therapy. However, recurrence of AF after PVI is common, often due to the inability to create durable ablation lesions surrounding the pulmonary veins (PV). Conventional radiofrequency (RF) ablation is typically performed with power set at 30-40 Watt for a duration of 20-30 seconds. Previous studies have shown that ablation with very higher power and shorter duration (vHPSD, 90W/4sec) may result in more continuous and more durable ablation lesions with a similar safety profile as compared to conventional ablation lesions. This new technique may consequently improve outcomes of RF ablation for AF. Moreover, HPSD ablation of AF may significantly reduce RF duration, which could lead to shorter anaesthesia, fluoroscopy and procedure duration.
Cardiac magnetic resonance imaging (CMR) enables studying cardiac volumes, function and atrial tissue characteristics. By applying this imaging strategy before ablation, and directly (<72 hours) and later (3 months) after ablation, transient (edema) and persistent (fibrosis) effects of RF ablation in the left atrial wall and surrounding tissues may be visualized and quantified.
The Q-POWER study aims to assess the effects of VHPSD RF ablation on 1) procedural characteristics, 2) acute and long-term ablation lesion formation and collateral tissue damage as assessed by CMR and 3) clinical outcomes in AF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •>18 years of age
- •AF and eligible for index PVI according to current ESC guidelines
排除标准
- •Unwilling or unable to give written informed consent
- •Prior left atrial ablation
- •Other left atrial arrhythmias including atrial flutters
- •Prior left atrial surgery
- •Severe mitral valve regurgitation
- •Contraindication for gadolinium-based contrast agents
- •Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia)
- •Renal insufficiency (eGFR < 30 ml/min)
研究组 & 干预措施
Paroxysmal or persistent atrial fibrillation patients
干预措施: Pulmonary vein isolation (Procedure)
结局指标
主要结局
Procedure duration
时间窗: Procedure
To study the effect of VHPSD ablation on procedure duration of PVI, compared with conventional Ablation Index-guided ablation.
次要结局
未报告次要终点
研究者
Cornelis P. Allaart
Prof. dr.
Amsterdam UMC, location VUmc
