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

缺血性室性心动过速(VT)导致了30万例突发心脏事件中的一半以上 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80,000美元)，而且不能治愈。接受ICD的患者会受到周期性电击的影响 停止室性心动过速的发作，这些电击可能会造成创伤。射频消融代表着一种潜在的 治疗室性心动过速的方法，而且成本比ICD低得多，但尽管射频消融已经 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却没有那么有效。一个 能够治疗室性心动过速的消融工具有可能消除对ICD植入物的需要， 大大降低治疗室上性心动过速的医疗保健系统成本，同时改善生活 受室性心动过速影响的患者。 我们已经开发了一种治疗室性心动过速的消融系统和导管。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型 消除心脏深部致心律失常组织所需的心脏组织体积 室壁。我们的技术能够处理比 传统的射频是因为生理盐水通过对流将射频产生的热量输送到组织中。我们 已经证明，我们的消融系统可以治愈梗塞动物模型中的室性心动过速。 我们的主要目标是进行一项20名患者的临床试验，以确定我们技术的安全性 并开始展示热疗系统治疗室上性心动过速的疗效。在此之前 开始人体临床试验，我们将完成验证和验证活动，以确保 系统的电气安全和导管材料的生物兼容性，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只梗死犬进行最终的安全性研究。 我们将在梅奥诊所进行这项有20名患者参加的研究。符合以下条件的患者将有资格参加这项研究 他们有反复发作的有症状的室速；如果他们之前的心脏导管VT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；如果目标是 植入的ICD已经治疗了心律失常。这项研究的主要安全终点 出院前无重大心脏不良事件(MACE) 70%以上的患者，并且没有潜在的严重不良事件 超过70%的患者在30天内与设备相关。主要疗效终点 研究的重点将是非诱导性的临床室速和临床相关瘢痕的治疗。

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.