Esophageal Cooling for AF Ablation
赞助:
University of Pennsylvania
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 7, 2018 | ||
| 首次发布日期e ICMJE | October 1, 2018 | ||
| 最后更新发布日期 | October 1, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | September 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
The occurrence rate of esophageal thermal injury between groups measured by EGD[ Time Frame: Day 1 to 2 ] The severity and size of esophageal injury between groups measured by EGD[ Time Frame: Day 1 to 2 ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Esophageal Cooling for AF Ablation | ||
| 正式标题 ICMJE | Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF) | ||
| 简要概况 | 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. |
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| 详细说明 | 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Randomized, blinded single center pilot study 盲法: Interventional 盲法描述: 主要目的: Prevention |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
40 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2019 | ||
| 预计主要完成日期 | September 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Patients above the age of 18 years old. 2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure. 3. Patients must be able to understand and critically review the informed consent form. Exclusion Criteria: 1. Patients whom are unable to provide informed consent. 2. Patients with contraindication to EGD. 3. History of prior AF ablation procedures. 4. Significant co-morbidities that preclude standard ablation procedure. 5. 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. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | University of Pennsylvania | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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