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临床试验/NCT06846502
NCT06846502进行中(未招募)不适用

High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation Using the QDOT MICRO™ Catheter - Q-POWER STUDY

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年6月21日最近更新:
适应症
干预措施

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

Experimental

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

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cornelis P. Allaart

Prof. dr.

Amsterdam UMC, location VUmc

研究点 (1)

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