Esophageal Injury of a Tip CF Sensing Ablation Catheter for HP-SD of Paroxysmal and Persistent AF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Proportion of the acute esophageal thermal injury (ETI)
研究概览
简要总结
This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are:
- Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen.
- Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development.
- Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.
详细描述
This study aims to estimate the proportion of esophageal thermal injury (ETI) as a result of the AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter immediately after and at 3, 6, and 12 months from the procedure, as well as describe their characteristics.
To be more sensitive and specific in detecting the presence of potentially chronic and progressing ETIs in esophageal ulcers and atrium-esophageal fistula, a minimally invasive esophagogastroscope will be used before (1-7 days) and after (1-3 days) the ablation procedure, with an internal comparison of the lesions observed. In addition, various clinical characteristics of the patients and descriptors of the ablation procedure (such as contact force, impedance, RF power, RF time, esophageal temperature, procedure times, etc.) will be collected and related to the presence of ETI.
The principal Medical Devices that will be used:
- Cardiac Mapping system Ensite X (Abbott Medical),
- Tip CF sensing catheter TactiFlex (Abbott Medical),
- High mapping density catheter (HD GRID/Advisor FL, Abbott Medical),
- Continuous temperature monitoring devices (Esotest Multi/Esotherm 7 poles, FIAB),
- Video-endoscope EXERA III HDTV dual focus GIF-HQ190 (Olympus).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial fibrillation and, according to current guidelines, indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter.
- •Able to sign the consent form.
排除标准
- •LVEF < 45%
- •Presence of thrombus in the left atrium
- •NYHA III/IV Class
- •Atrial diameter > 50mm
- •Moderate or severe valve dysfunction
- •Implanted ICD/CRT-D
- •Life expectancy < 1 year
- •Uncontrolled Hyperthyroidism
- •Hypertrophic or dilatative cardiomyopathy
- •Kidney failure (eGFR < 30)
- •Body Mass Index (BMI)> or = 35
- •Participation in another clinical trial in the past 3 months
- •Inability to express informed consent for the study
- •Patients with esophageal pathologies and a history of gastritis
- •Pregnancy (ascertained by performing the HCG test), breastfeeding, pregnancy planned during the study, or fertile female subjects who refused to use a highly effective contraceptive measure.
结局指标
主要结局
Proportion of the acute esophageal thermal injury (ETI)
时间窗: 1-3 days after AF ablation procedure
Evaluate the acute proportion of the esophageal thermal injury (ETI)
次要结局
- AF ablation procedure times(1 day)
- AF recurrences(12 months after AF ablation procedure)
- Factors influencing RF procedure on ETI development(1-3 days after AF ablation procedure)
- Esophageal temperature by an esophageal continuous monitoring device(during AF ablation procedure)
- ETI monitoring(12 months after AF ablation procedure)
- Serious and no serious adverse events(12 months after AF ablation procedure)