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临床试验/NCT05780996
NCT05780996招募中不适用

Optimization of PVI Strategy Using QDOT Catheter. What is the Proper Energy Level for Anterior Wall of Pulmonary Veins- Intraprocedural Efficacy Comparison Between HSPD and vHPSD (The A-Q-RATE POWER Trial)

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
2
主要终点
Acute procedural success

研究概览

简要总结

This study is a prospective, randomized controlled study to evaluate intraprocedural efficacy of anterior aspects of pulmonary veins insolation between very High Power Short Duration (vHPSD) and High Power Short Duration (HPSD) in patient with paroxysmal or persistent Atrial Fibrillation.

详细描述

This study is a dual-center, prospective, randomized controlled study to evaluate intraprocedural efficacy of anterior aspects of pulmonary veins isolation between very High Power Short Duration (vHPSD) and High Power Short Duration (HPSD) in patient with paroxysmal or persistent atrial fibrillation (AF).

Catheter ablation of atrial fibrillation with circumferential pulmonary vein isolation is an well-established method of treatment, particularly in symptomatic patients with atrial fibrillation (AF) who are ineffective or refractory to pharmacological treatment. Recurrence of pulmonary veins conduction is considered as a risk factor for future recurrence of AF. This may be partly related to the incomplete scar formation during the index ablation procedure. Constant technological progress (i.e. ablation catheters with contact force) has led to greater efficiency in obtaining complete isolation of pulmonary veins, achieving nearly 90% success rate in 12-month follow-up paroxysmal AF (CLOSE protocol). The duration of the RF application depends on the ablation index (AI), which proves that the energy has been effectively delivered to the myocardium. Currently, AI values are considered representative of RF power up to 50W. When energy above 50 W was used, the scar size was shown to be smaller than when the same AI value was used but with higher power. The safety and efficacy of novel ablation catheter QDOT (Biosense Webster, Irvine, CA, USA), that allows to deliver very high and high-power short-duration ablation, was already proven in clinical trials (QDOT FAST, Q-FFICIENCY). The benefits from using very high power short-duration ablation include: 1) shortening the duration of the procedure, 2) reducing the volume of fluids administered through the ablation electrode during RF application, which may be important in patients with heart and kidney failure, 3) reducing the frequency of collateral damages to surrounding structures of the heart (e.g. oesophagus). One of the differences related to the biophysics of RF applications between high and low energy is the range of penetration into the muscle tissue, which could impact on effectiveness of ablation. It was shown that lesions performed with vHPSD were smaller (up to 2,9 mm deep) compared to HPSD or conventional power with target AI. It is attractive for posterior wall of left atrium and can reduce peri-procedural complications. However vHPSD could be insufficient in some regions of anterior wall of the left atrium, which thickness may vary from 1 to 4 mm. Our research hypothesis is that integrated approach with different energies depending on the left atrium location is safe and lead to better efficacy than use of only vHPSD ablation in terms of first pass isolation.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient scheduled for their first AF ablation procedure
  • Written informed consent
  • Paroxysmal or persistent AF

排除标准

  • previous ablation procedure with pulmonary vein isolation
  • lack of written informed consent

结局指标

主要结局

Acute procedural success

时间窗: During ablation.

First pass isolation of anterior wall of pulmonary veins.

次要结局

  • Number of additional RF application needed to obtain pulmonary vein isolation(during ablation)
  • percentage of pulmonary vein pairs isolated with first encirclement(during ablation)
  • Incidence of peri-procedural complications(during ablation)
  • Total procedure duration(during ablation)
  • Change of heart rhythm after right pulmonary veins isolation(during ablation)
  • Fluoroscopy time(during ablation)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Piotr Gardziejczyk, MD

MD

Medical University of Warsaw

研究点 (2)

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