Eliminating Ventricular Tachycardia: First in Human Clinical Trial using the Durablate™ Catheter

消除室性心动过速：首次使用 Durablate™ 导管进行人体临床试验

• 批准号: 9255776
• 负责人: MICHAEL G CURLEY
• 金额: $ 167.31万
• 依托单位: THERMEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-21 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9255776
• 关键词: Ablation; Affect; Aneurysm; Animal Model; Animals; Anti-Arrhythmia Agents; Arrhythmia; Canis familiaris; Cardiac; Cardiac Volume; Caring; Catheters; Cessation of life; Chronic; Cicatrix; Clinic; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Complication; Computer software; Convection; Defibrillators; Devices; Electrodes; Electromagnetics; Eligibility Determination; Ensure; Etiology; Event; Feasibility Studies; Funding; Goals; Grant; Healthcare Systems; Heart; Heart Atrium; Hospitals; Human; Implant; Implantable Defibrillators; Injectable; Life; Life Expectancy; Liquid substance; Liver neoplasms; Mechanics; Medical Device; Medicare; Medicare/Medicaid; Methods; Modeling; Monitor; Myocardium; National Heart, Lung, and Blood Institute; Operative Surgical Procedures; Pain; Patients; Perforation; Performance; Periodicity; Phase; Primary Prevention; Procedures; Pump; Quality of life; Radiofrequency Interstitial Ablation; Recurrence; Risk; Safety; Saline; Serious Adverse Event; Shock; Small Business Innovation Research Grant; Steam; Sterility; Sterilization; Supraventricular tachycardia; System; Techniques; Technology; Testing; Thermal Ablation Therapy; Thermal Conductivity; Thrombus; Time; Tissues; United States; Ventricular; Ventricular Arrhythmia; Ventricular Tachycardia; base; biomaterial compatibility; clinically relevant; cost; effusion; electric impedance; hemodynamics; human study; implantation; improved; killings; prevent; programs; research clinical testing; safety study; safety testing; standard of care; structural heart disease; subcutaneous; success; sudden cardiac death; symposium; technique development; tool; verification and validation

Ischemic ventricular tachycardia (VT) causes more than half of the 300,000 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 $80,000) and not curative. Patients who receive ICDs are subject to periodic shocks to halt episodes of VT, and those shocks can be traumatic. RF ablation represents a potential method for curing VT, and at a much lower cost than ICDs, but while RF ablation has been successful at treating atrial arrhythmias, it has not so far been as effective at treating VT. An ablation tool capable of treating VT has the potential to eliminate 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. We have developed an ablation system and catheter for 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 deep in the ventricular wall. Our technology is capable of treating much larger volumes of tissue than conventional RF because saline carries the heat generated by RF into tissue by convection. We have demonstrated that our ablation system can cure VT in an infarcted animal model. Our primary aim is to carry out a 20-patient clinical trial to establish the safety of our technology and to begin to demonstrate the efficacy of the Thermedical system for treatment of VT. Before beginning the human clinical trial, we will complete verification and validation activities to ensure the electrical safety of the system and the biocompatibility of the catheter materials, and to validate the catheter packaging and sterilization. Additionally, prior to the human trial we will carry out a final safety study on 8 infarcted canines. We will conduct the 20-patient study at the Mayo Clinic. 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 ischemic structural heart disease; and if a target arrhythmia has been treated by an implanted ICD. The primary safety endpoints of this study will be the absence of Major Adverse Cardiac Events (MACE) prior to hospital discharge in more than 70% of the patients, and the absence of serious adverse events that are potentially device related within 30 days for more than 70% of the patients. The primary efficacy endpoints of the study will be non-inducibility of the clinical VT and treatment of clinically relevant scar.

缺血性室性心动过速（VT）导致30万例突发性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80，000美元），而且不具有治疗作用。植入ICD的患者会受到周期性电击， 停止室性心动过速的发作，这些电击可能是创伤性的。射频消融是一种潜在的 治疗VT的方法，并且成本比ICD低得多，但是尽管RF消融已经被 虽然它在治疗房性心律失常方面是成功的，但迄今为止它在治疗VT方面并不有效。一个 能够治疗VT的消融工具有可能消除对ICD植入物的需要， 大大降低了治疗VT的医疗保健系统的成本，同时也改善了患者的生活， 室性心动过速的患者 我们开发了一种用于治疗室性心动过速的消融系统和导管。我们的技术 沿着射频能量输送加热的生理盐水，其独特之处在于能够治疗大面积 消除位于心脏深部的致瘤组织所需的心脏组织体积 心室壁我们的技术能够治疗比 因为盐水通过对流将RF产生的热量携带到组织中。我们 已经证明我们的消融系统可以在梗塞动物模型中治愈VT。 我们的主要目标是进行20名患者的临床试验，以确定我们的技术的安全性 并开始证明Thermedical系统治疗室性心动过速的有效性。之前 开始人体临床试验时，我们将完成验证和确认活动，以确保 系统的电气安全性和导管材料的生物相容性，以及 确认导管包装和灭菌。此外，在人体试验之前，我们将 对8只梗死犬进行最终安全性研究。 我们将在马约诊所进行20例患者的研究。符合以下条件的患者将有资格参加研究： 患有复发性、症状性室性心动过速;如果既往心脏导管室性心动过速消融失败;如果 心律失常的病因与缺血性结构性心脏病有关;如果靶点 心律失常已通过植入式ICD治疗。本研究的主要安全性终点 出院前未发生重大心脏不良事件（MACE）， 超过70%的患者，并且没有潜在的严重不良事件 超过70%的患者在30天内与器械相关。主要疗效终点 本研究的目的是不诱导临床室性心动过速和治疗临床相关瘢痕。