Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation

食管冷却疗法在预防心房颤动期间热损伤中的应用

基本信息

批准号：
10480805
负责人：
DAVID J CALLANS
金额：
$ 170万
依托单位：
ADVANCED COOLING THERAPY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-15 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10480805
关键词：
Ablation Acute Adverse event Arrhythmia Atrial Fibrillation Body Temperature Boston Cardiac Cardiac ablation Clinical Clinical Trials Clinical effectiveness Complication Critical Care Devices Diagnosis Effectiveness Esophageal Tissue Esophageal injury Esophagus Fistula Fluoroscopy Freedom Frequencies Funding Goals Grant Health Care Costs Incidence Injury Intervention Investigation Label Left atrial structure Lesion Life Location Longterm Follow-up Manufacturer Name Measures Mechanics Medical Medical Care Costs Medical Device Methods Monitor Multicenter Studies Outcome Patient Care Patients Persons Pharmacologic Substance Phase Pre-Clinical Model Prevention strategy Prevention therapy Problem Solving Procedures Protocols documentation Pulmonary veins Radiofrequency Catheter Ablation Radiofrequency Interstitial Ablation Randomized Randomized Clinical Trials Reproducibility Risk Safety Sales Seeds Severities Silicones Site Small Business Innovation Research Grant Technology Temperature Time Tissues Tube United States Variant clinical implementation commercialization design heat exchanger heat injury improved industry partner innovation mathematical model novel prevent prospective radio frequency randomized controlled study standard of care stroke risk

项目摘要

ABSTRACT Atrial fibrillation (AF) is the most common type of heart arrhythmia; an estimated 2.7 to 6.1 million people in the United States have been diagnosed with AF and this number is expected to increase. Cardiac catheter ablation is an effective AF treatment and is performed up to a quarter million times per year in the US; however, safety concerns exist. Endoscopically detected esophageal lesions (EDELs) occur in 15-40% of cases and can progress into serious injuries, including atrioesophageal fistula (AEF), which is fatal in most cases. Current prevention strategies include reducing ablation energy applied to the left atrium, monitoring esophageal temperature, and mechanically displacing the esophagus. None of these methods have demonstrated reproducible clinical effectiveness in preventing or reducing severe EDELs or AEF. Previous studies have shown that active cooling reduces thermal esophageal injury but challenges in clinical implementation limited commercialization of this approach. The ensoETM, originally designed and successfully commercialized for whole-body temperature modulation by Attune Medical using SBIR seed funding provides the first scalable solution for active esophageal cooling during cardiac ablation. The ensoETM device is a novel device FDA- cleared for core temperature modulation using a multi-lumen silicone tube placed in the esophagus to cool or warm a patient. During radiofrequency (RF) ablation procedures, the ensoETM device acts as a heat sink for RF energy inadvertently delivered to the esophagus, thus minimizing unwanted tissue damage. Pilot randomized, controlled studies show a large and consistent effect size, and suggest benefits in efficiency and fluoroscopy reduction as well, warranting larger, multi-site investigation. The Specific Aims of this project are: 1) Determine the occurrence rate of esophageal thermal injury and compare the severity of esophageal injury between groups with and without ensoETM; 2) Measure the impact of ensoETM on procedural efficiency and fluoroscopy use; 3) Determine specific ensoETM design changes and cooling protocol changes necessary for optimization. Demonstration of these aims will pave the way for commercialization of this innovative approach to esophageal protection, and support an expanded FDA label claim, making catheter ablation safer for the hundreds of thousands of people who currently undergo AF ablation per year, and expanding an alternative to expensive and life-long pharmaceutical treatment.

抽象的心律失常（AF）是心律不齐的最常见类型；估计有2.7至610万人美国已被诊断出患有AF，预计这一数字将增加。心脏导管消融是一种有效的AF治疗方法，在美国每年进行高达25万次；但是，安全存在关注。在15-40％的病例中发生内镜下检测到的食管病变（埃德尔），可以陷入严重伤害，包括心动过管瘘（AEF），在大多数情况下是致命的。当前的预防策略包括减少对左心房应用的消融能量，监测食道温度并机械地置换食道。这些方法都没有证明可再现的临床有效性在预防或减少严重的埃德尔或AEF方面。先前的研究已有表明主动冷却减少了热食道损伤，但临床实施有限的挑战这种方法的商业化。 ENSOETM最初设计和成功商业化使用SBIR种子资金通过Attune Medical调制全身温度温度在心脏消融过程中进行活跃的食管冷却的溶液。 ENSOETM设备是一种新型设备FDA- 使用放置在食道冷却或冷却或温暖病人。在射频（RF）消融过程中，ENSOETM设备充当散热器 RF能量无意间输送到食道，从而最大程度地减少了不需要的组织损伤。飞行员随机，对照研究表明效果大小较大，并提出了效率的好处还要减少透视镜检查，保证更大的多站点研究。该项目的具体目的是： 1）确定食管热损伤的发生率，并比较食管损伤的严重程度在有和没有ENSOETM的组之间； 2）衡量ENSOETM对程序效率和透视镜使用； 3）确定特定的ENSOETM设计更改和冷却协议的更改优化。这些目标的演示将为这种创新方法的商业化铺平道路为食管保护，并支持扩大的FDA标签主张，使导管消融更安全目前每年每年进行AF消融的成千上万的人，并扩大了替代方案昂贵且终身的药物治疗。