Eliminating Ventricular Tachycardia: Pivotal Clinical Trial using the Durablate® Catheter

消除室性心动过速：使用 Durablate® 导管的关键临床试验

• 批准号: 10762302
• 负责人: MICHAEL G CURLEY
• 金额: $ 134.23万
• 依托单位: THERMEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-12 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10762302
• 关键词: 3-Dimensional; Ablation; Acute; Affect; Agreement; Aneurysm; Anti-Arrhythmia Agents; Arrhythmia; Award; Breakthrough device; Cardiac; Cardiac Volume; Cardiovascular system; Catheters; Cessation of life; Characteristics; Chronic; Circulation; Clinical; Clinical Research; Clinical Trials; Communities; Convection; Defibrillators; Development; Devices; Dimensions; Electrophysiology (science); Eligibility Determination; Etiology; Event; FDA approved; Funding; Goals; Guidelines; Healthcare Systems; Heart Atrium; Image; Implant; Implantable Defibrillators; Incidence; Infarction; Ischemia; Lesion; Life; Life Expectancy; Liver neoplasms; Location; Magnetic Resonance Imaging; Maps; Mechanics; Medicare; Medicare/Medicaid; Methods; Modernization; Monitor; Myocardium; Pain; Patients; Perforation; Persons; Pharmaceutical Preparations; Physicians; Primary Prevention; Procedures; Publishing; Quality of life; Radiofrequency Interstitial Ablation; Recurrence; Refractory; Safety; Saline; Shock; Small Business Innovation Research Grant; Sterility; Stroke; Supraventricular tachycardia; Surface; System; Tachycardia; Techniques; Technology; Thermal Ablation Therapy; Thermal Conductivity; Tissues; United States; United States National Institutes of Health; Validation; Ventricular; Ventricular Arrhythmia; Ventricular Tachycardia; arm; biomaterial compatibility; care costs; cost; curative treatments; editorial; effusion; experience; first-in-human; human study; implantation; improved; patient population; prevent; reconstruction; research clinical testing; response; safety testing; standard of care; structural heart disease; success; sudden cardiac death; symposium; tool

Ventricular tachycardia (VT) causes more than half of the 170,000–450,000 sudden cardiac deaths (SCD) that occur annually in the United States. Implantable cardioverter defibrillators (ICDs) are the standard of care, but they are expensive (the total cost of an ICD implant exceeds $50,000) and not curative. Patients who receive ICDs are subject to shocks to halt episodes of VT, and those shocks can be painful and traumatic. RF ablation represents a potential method for curing VT, at a much lower cost than ICDs, but while RF ablation has been successful at treating atrial arrhythmias, it is not as effective at treating VT. An ablation tool capable of treating VT has the potential to improve ICD therapy by eliminating shocks or even the need for ICD implants, greatly reducing the cost to the health care system of treating VT while also improving the lives of patients affected by VT. Recent advances in 3-D reconstruction of CT or MRI images and with merging those images with electroanatomic maps have made identification of the tissue that needs to be ablated easier. We have developed the ablation tool that can reliably treat all VT foci. We have developed the Durablate® Catheter and SERF ablation specifically the treatment of VT. Our technology delivers heated saline along with RF energy and is unique in its ability to treat the large volumes of cardiac tissue necessary to eliminate arrhythmogenic tissue located either on the endocardial surface or deep in the ventricular wall. Our technology can treat much larger volumes of tissue than conventional RF because saline carries the heat generated by RF into tissue by convection. We also have fine control over the size of the ablated lesion since we have control over the amount of saline delivered. SERF lesions can be as small or as large as the physician needs and they will be the size the physician calls for. We have successfully concluded a small first-in-human study whose results were recently published in Circulation: Arrhythmia and Electrophysiology. An accompanying editorial described the results as “impressive” in a patient population with “clinical characteristics that would intimidate even the most optimistic and experienced VT ablation enthusiasts.” The FDA has awarded our technology Breakthrough Device Designation and has approved our IDE for our pivotal clinical trial. We will conduct the 154-patient single-arm study at seven centers. Patients will be eligible for the study if they have recurrent, symptomatic VT; if they have failed prior cardiac catheter VT ablation; if the etiology of the arrhythmia is related to structural heart disease; or if a target arrhythmia has been treated by an implanted ICD. Successful completion of this clinical trial will result in the US clearance for the Durablate catheter and will offer an underserved patient population a better quality of life and the possibility of a cure.

170,000–450,000 例心源性猝死中，一半以上是由室性心动过速 (VT) 引起的 美国每年都会发生死亡（SCD）。植入式心脏复律除颤器 (ICD) 是护理标准，但价格昂贵（ICD 植入的总成本 超过 50,000 美元）且没有治疗作用。接受 ICD 的患者会因电击而停止 室性心动过速发作，这些电击可能会带来痛苦和创伤。射频消融代表 治疗 VT 的潜在方法，其成本比 ICD 低得多，但射频消融已 它在治疗房性心律失常方面取得了成功，但在治疗室性心动过速方面效果不佳。消融工具 能够治疗 VT 有可能通过消除休克甚至改善 ICD 治疗 对 ICD 植入的需求，大大降低了医疗保健系统治疗 VT 的成本 同时还能改善受 VT 影响的患者的生活。 3D 领域的最新进展 重建 CT 或 MRI 图像并将这些图像与电解剖图合并 使得识别需要消融的组织变得更加容易。我们开发了 可以可靠治疗所有 VT 病灶的消融工具。 我们开发了 Durablate® 导管和 SERF 消融术，专门用于治疗 VT。我们的技术提供加热盐水和射频能量，其独特之处在于能够 治疗大量心脏组织，以消除位于的致心律失常组织 位于心内膜表面或心室壁深处。我们的技术可以治疗很多 由于盐水携带射频产生的热量，因此可以比传统射频处理更大体积的组织 通过对流进入组织。我们还可以很好地控制消融病变的大小，因为我们 控制生理盐水的输送量。 SERF 病变可小可大 医生需要，并且它们将是医生要求的尺寸。 我们成功地完成了一项小型首次人体研究，其结果最近公布 发表在《循环：心律失常和电生理学》上。随附的社论 将具有“临床特征的患者群体”的结果描述为“令人印象深刻” 即使是最乐观、最有经验的 VT 消融爱好者也会感到害怕。”美国食品药品监督管理局 已授予我们的技术突破性设备称号，并批准我们的 IDE 我们的关键临床试验。 我们将在七个中心进行 154 名患者的单组研究。患者将有资格获得 研究是否患有复发性、有症状的室性心动过速；如果他们之前的心导管 VT 失败 消融；心律失常的病因是否与结构性心脏病有关；或者如果一个目标 心律失常已通过植入式 ICD 进行治疗。本次临床试验的顺利完成将 导致 Durablate 导管在美国获得许可，并将为服务不足的患者提供服务 人口更好的生活质量和治愈的可能性。