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.

室性心动过速（VT）导致170，000 - 450，000例突发心脏病中的一半以上 死亡（SCD），每年发生在美国。植入式心律转复除颤器 （ICD）是护理标准，但它们昂贵（ICD植入物的总成本 超过50，000美元），而且不具有治疗作用。植入ICD的患者会受到电击， 室性心动过速发作，这些电击可能是痛苦和创伤性的。射频消融是一种 一种潜在的治疗室性心动过速的方法，成本比ICD低得多，但尽管射频消融已被 虽然它在治疗房性心律失常方面是成功的，但在治疗VT方面并不有效。一个消融工具 能够治疗室性心动过速的药物有可能通过消除电击甚至 ICD植入物的需求，大大降低了医疗保健系统治疗VT的成本 同时也改善了室性心动过速患者的生活。3-D的最新进展 CT或MRI图像的重建以及将这些图像与电解剖图合并 已经使得需要消融的组织的识别更容易。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，专门用于治疗 佛蒙特州我们的技术提供加热的生理盐水沿着射频能量，其独特之处在于能够 治疗大量的心脏组织，以消除位于 或者在心室壁的内表面或者在心室壁的深处。我们的技术可以治疗 组织体积比传统射频大，因为盐水携带射频产生的热量 通过对流进入组织我们还可以很好地控制消融病灶的大小，因为我们 控制输送的盐水量。SERF损伤可以小到或大到 医生需要的，他们将是医生要求的大小。 我们已经成功地完成了一项小型的首次人体研究，其结果最近 发表在Circulation：Arrhythmia and Electrophysiology。随后的社论 描述了在具有“临床特征， 即使是最乐观、最有经验的室性心动过速消融术爱好者也会感到害怕。”FDA的 已授予我们的技术突破设备称号，并批准我们的IDE用于 我们关键的临床试验 我们将在7个中心进行154例患者的单组研究。患者将有资格 如果他们有复发性、有症状的室性心动过速;如果他们之前心导管室性心动过速失败， 消融;如果心律失常的病因与结构性心脏病有关;或者如果靶点 心律失常已通过植入式ICD治疗。本临床试验的成功完成将 导致美国批准Durablate导管，并将为服务不足的患者提供 人口的生活质量和治愈的可能性。