A Prospective Randomized Study on the Effect of Oesophageal Temperature Monitoring on the Incidence of Esophageal Lesions After Left Atrial Ablation for the Treatment of Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of esophageal lesions
研究概览
简要总结
It's a randomized pilot study to evaluate the incidence of esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation according to three different strategies of esophageal temperature monitoring.
These patients will be divided into 3 groups with different strategies of esophageal temperature monitoring: group 1 without monitoring, group 2 monitoring with single probe thermometer and group 3 monitoring with multi-probe thermometer.
The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy.
详细描述
This is a randomized pilot study on the effect of oesophageal temperature monitoring on the esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation (AF).
Sixty patients with paroxysmal AF or persistent and without previous AF ablation with indication of AF ablation will be selected to be included at the study.
After informed consent, these patients will be randomized in 3 groups with different strategies of esophageal protection for radiofrequency application in the posterior wall of the left atrium, by randomization in a ratio of 1: 1: 1 between groups.
Group I: no esophageal temperature monitoring technique. Group II: monitoring of esophageal temperature during radiofrequency applications in the posterior wall of the left atrium, with unipolar thermometer.
Group III: oesophageal temperature monitoring during radiofrequency applications in the posterior wall of the left atrium, with a multipolar and self expandable thermometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with paroxysmal or persistent AF, diagnosed by electrocardiogram, 24-hour Holter, or monitors of implantable or non-implantable events, with at least one episode of AF up to 12 months before the procedure. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form.
排除标准
- •Atrial thrombus in the left atrium, history of AF ablation, history of cardiac surgery, contraindication to anticoagulation, permanent AF, New York Heart Association functional class III or IV, stroke in the last 3 months, pregnancy, history blood clotting abnormalities, previous oesophageal surgery, or advanced chronic kidney disease (creatinine > 2.5 mg/dl).
结局指标
主要结局
Incidence of esophageal lesions
时间窗: Within three days after the ablation procedure.
Incidence of esophageal lesions evaluated by upper digestive endoscopy
次要结局
- Difference in the size of the esophageal lesions(Within three days)
- Isolation rate of pulmonary veins at the end of ablation.(End of the procedure)
- Duration of the AF ablation procedure(End of the procedure)
- Rate of recurrence of AF(Six months)
- Maximum esophageal temperature reached during ablation.(During procedure.)
- Incidence of atrio-esophageal fistulas(Six months)
- Persistence of esophageal lesions in the second upper endoscopy.(Between 3 to 30 days of the procedure)
研究者
Mauricio Ibrahim Scanavacca
Arrhythmia Clinical Unit Director
University of Sao Paulo General Hospital