Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Number and Percentage of Participants With Esophageal Thermal Injury
研究概览
简要总结
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
详细描述
The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients above the age of 18 years old.
- •Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
- •Patients must be able to understand and critically review the informed consent form.
排除标准
- •Patients whom are unable to provide informed consent.
- •Patients with contraindication to EGD.
- •History of prior AF ablation procedures.
- •Significant co-morbidities that preclude standard ablation procedure.
- •Patient is ineligible for EnsoETM placement due to:
- •Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
- •Known ingestion of acidic or caustic poisons within the prior 24 hours.
- •Patients with <40 kg of body mass.
研究组 & 干预措施
Esophageal Cooling
Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).
干预措施: Esophageal Cooling (Device)
Control
Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).
干预措施: Control (Device)
结局指标
主要结局
Number and Percentage of Participants With Esophageal Thermal Injury
时间窗: Day 1 to 2
Any injury, occurrence rate measured by EGD
Number and Percentage of Participants With Esophageal Injury Based on Severity
时间窗: Day 1 to 2
The severity of injury measured by EGD
次要结局
- Posterior Wall Ablation Parameters: Temperature(Day 0)
- Posterior Wall Ablation Parameters(Day 0)
- Occurrence of Acute PV Reconnection(Day 0)