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

基本信息

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
项目类别：
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

项目摘要

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.

30 万例心脏骤停中，一半以上是由缺血性室性心动过速 (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 80,000 美元）且没有治疗作用。接受 ICD 的患者会受到周期性电击停止 VT 发作，这些电击可能会造成创伤。射频消融代表了一种潜力治疗 VT 的方法，且成本比 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，但迄今为止在治疗室性心动过速方面还没有那么有效。一个能够治疗 VT 的消融工具有可能消除 ICD 植入的需要，大大降低医疗保健系统治疗 VT 的成本，同时改善人们的生活受 VT 影响的患者。我们开发了用于治疗 VT 的消融系统和导管。我们的技术提供加热盐水和射频能量，其独特的能力是治疗大消除位于心脏深处的致心律失常组织所需的心脏组织体积心室壁。我们的技术能够处理比与传统射频不同，因为盐水通过对流将射频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治愈梗死动物模型中的室性心动过速。我们的主要目标是进行 20 名患者的临床试验，以确定我们技术的安全性并开始证明热疗系统治疗 VT 的功效。前开始人体临床试验后，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，以及验证导管包装和灭菌。此外，在人体试验之前我们将对 8 只梗塞犬进行最终安全性研究。我们将在梅奥诊所进行 20 名患者的研究。患者将有资格参加该研究，如果他们患有复发性、有症状的室性心动过速；如果他们之前的心导管室速消融失败；如果心律失常的病因与缺血性结构性心脏病有关；如果一个目标心律失常已通过植入式 ICD 进行治疗。本研究的主要安全终点出院前未出现严重不良心脏事件 (MACE) 超过 70% 的患者，并且没有出现可能导致严重不良事件的情况超过 70% 的患者在 30 天内获得了与设备相关的信息。主要疗效终点该研究的重点将是非诱导性临床VT和临床相关疤痕的治疗。