Impact of Pulmonary Vein Isolation (PVI) Line Modification Based on the Multidetector Computed Tomography (MDCT)-Derived Fingerprinted Esophageal Distance to the Posterior Wall of the Left Atrium, on the Esophageal Temperature Raise Measured With an Intraluminal Esophageal Temperature Monitoring Lead. A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Proportion of participants presenting a temperature rise as measured with a luminal esophageal temperature probe during radiofrequency delivery. The temperature is measured in Celsius degrees.
研究概览
简要总结
A multimodal strategy integrating esophageal visualization with the multidetector computed tomography (MDCT) and simultaneous temperature monitoring has never been put into practice. We have developed an isodistance map (esophageal print) to depict the atrio-esophageal relationship and to analyze the esophageal position peri procedurally. The present randomized study intends to analyze the usefulness of the esophageal print in predicting local thermal heating of the esophagus.
详细描述
Primary objective: to validate the usefulness of the esophageal print in avoiding temperature rises caused by radiofrequency (RF) application at the left atrial (LA) posterior wall during atrial fibrillation ablation
Secondary objectives:
- to establish if there is a linear relationship between intraesophageal temperature rise and atrio-esophageal distance as calculated by the MDCT-derived esophageal print.
- to analyze the need for ablation line modification.
- to analyze the need for energy (power settings, ablation index, ablation time, etc.) modification.
- to develop a new multimodal approach to esophageal monitoring during AF/AT ablation.
Interventions
- Pre-procedural scan and Esophageal Isodistance Print
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Indication for any atrial fibrillation or left atrial flutter ablation procedure.
- •Documented episodes of atrial arrhythmia (AF/AT/AFL)
- •Signed informed consent.
排除标准
- •Age < 18 years.
- •Pregnancy.
- •Impossibility to perform CT Scan.
- •Impossibility to perform transesophageal echocardiography or to insert esophageal temperature monitoring probe.
- •Concomitant investigation treatments.
- •Medical, geographical and social factors that make study participation impractical
- •Inability to give written informed consent.
- •Patient's refusal to participate in the study.
研究组 & 干预措施
Intervention group or "PRINT" group
The ablation line previously drawn will be modified regarding the esophageal print position in order to avoid RF application within the red layer of the esophageal print, which is the zone where the atrioesophageal distance is shorter. The maximal distance and the area between the original line and the modified line will be noted. In cases when ablation through the red layer is unavoidable, the delivered energy can be lowered to an ablation index (AI) of 300 regardless of the local wall thickness. If the temperature rises above 39℃, ablation will be immediately stopped, and energy will be reduced.
干预措施: Modification of the pulmonary vein ablation line (Procedure)
Control group
The ablation line will not be modified from the original one drawn before randomization and RF applications will follow the regular path. If the temperature rises above 39℃, ablation will be immediately stopped, and energy will be reduced.
干预措施: Regular PVI ablation (Procedure)
结局指标
主要结局
Proportion of participants presenting a temperature rise as measured with a luminal esophageal temperature probe during radiofrequency delivery. The temperature is measured in Celsius degrees.
时间窗: 1 day
Number of intraesophageal temperature rises above 39°C or absolute temperature raises of 2°C degrees. The chosen probe is St Jude
次要结局
- Proportion of patients needing ablation power or ablation time modification owing to esophageal presence in the immediate posterior wall .(1 day)
研究者
Antonio Berruezo, MD, PhD
Head of the Arrhytmia Unit
Centro Medico Teknon