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)占17万-45万例心脏骤停患者的一半以上 美国每年发生的死亡(SCD)。植入型心律转复除颤器 (ICD)是护理的标准，但它们很昂贵(ICD植入的总成本 超过50,000美元)并且不能治愈。接受ICD的患者会受到电击而停止工作 室性心动过速的发作，这些电击可能是痛苦和创伤的。射频消融是一种 治疗室性心动过速的潜在方法，成本比ICD低得多，但射频消融已经 它在治疗房性心律失常方面很成功，但在治疗室性心动过速方面效果不佳。一种消融工具 能够治疗室性心动过速有可能通过消除电击甚至是电击来改进ICD治疗 ICD植入物的需求，极大地降低了医疗保健系统治疗VT的成本 同时也改善了受VT影响的患者的生活。三维技术的最新进展 CT或MRI图像的重建及其与电解剖图的合并 使得识别需要消融的组织变得更容易。我们已经开发了 能够可靠地治疗所有VT病灶的消融工具。 我们已经开发了Durablate®导管和SERF消融术，专门用于治疗 VT.我们的技术提供加热的生理盐水和射频能量，其独特的能力是 治疗大量的心脏组织，以消除定位的致心律失常组织 要么在心内膜表面，要么在室壁深处。我们的技术可以治疗很多 组织体积比传统射频更大，因为生理盐水携带射频产生的热量 通过对流进入组织。我们也很好地控制了消融病变的大小，因为我们 可以控制生理盐水的输入量。农奴的损伤可以小到 内科医生需要的，他们将是医生要求的尺寸。 我们已经成功地完成了一项首次在人类中进行的小型研究，其结果是最近公布的 发表在《循环：心律失常和电生理学》上。随附的社论 将研究结果描述为在患者群体中的“令人印象深刻的”，该患者群体具有“ 即使是最乐观和最有经验的VT消融爱好者也会被吓倒。美国食品和药物管理局 已获得我们的技术突破设备称号，并已批准我们的IDE 我们的关键临床试验。 我们将在七个中心进行154名患者的单臂研究。患者将有资格 研究他们是否有复发、有症状的VT；如果他们之前的心脏导管VT失败 消融；如果心律失常的病因与结构性心脏病有关；或者如果目标是 植入的ICD已经治疗了心律失常。这项临床试验的成功完成将 导致美国批准硬膜外消融导管，并将提供一个服务不足的患者 人们有了更好的生活质量和治愈的可能性。