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Novel Catheter for Treatment of Ventricular Tachycardia

治疗室性心动过速的新型导管

基本信息

批准号：
7539089
负责人：
MICHAEL G CURLEY
金额：
$ 130.4万
依托单位：
THERMEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
起止时间：
1999-09-29 至 2011-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7539089
关键词：
3-Dimensional Ablation Acute Address Aneurysm Animal Model Animals Anti-Arrhythmia Agents Arrhythmia Biocompatible Canis familiaris Catheters Chronic Cicatrix Class Clinic Clinical Clinical Research Clinical Trials Computer software Defibrillators Depth Development Devices Diagnostic Electrodes Electromagnetics Ensure Extracellular Space Funding Agency Heart Heating Hospitals Human Implant Implantable Defibrillators Industry Infarction Injection of therapeutic agent Lesion Liver neoplasms Measures Medical Methods Modeling Molds Monitor Multi-Institutional Clinical Trial Myocardium Patients Pennsylvania Perforation Performance Phase Positioning Attribute Public Health Pump Quality of life Radiofrequency Catheter Ablation Radiofrequency Interstitial Ablation Rate Safety Saint Jude Children&apos s Research Hospital Saline Shock Site Standards of Weights and Measures Sterility Sterilization for infection control Supraventricular tachycardia System Tachycardia Techniques Technology Testing Tetradecanoylphorbol Acetate Thermal Ablation Therapy Thermal Conductivity Thrombus Tissues Treatment Efficacy United States United States Food and Drug Administration Universities Validation Ventricular Ventricular Arrhythmia Ventricular Tachycardia Woman base biomaterial compatibility cost design effusion ergonomics hemodynamics implantation improved in vivo novel pre-clinical radiofrequency sensor soft tissue success sudden cardiac death symposium

项目摘要

DESCRIPTION (provided by applicant): Ischemic ventricular tachycardia (VT) is a contributing cause to more than half of the 300,000 sudden cardiac deaths that occur annually in the United States. Implantable cardioverter defibrillators (ICDs) are the standard therapy but they are expensive the total cost of an ICD implant approaches $50,000 and the United States spends more than $2.2B on these implants annually. ICDs are effective, but not curative up to half of the patients who receive ICDs develop new sites of VT that are unresponsive to the defibrillator, requiring them to be put on antiarrhythmia drugs at additional cost. And 55,000 ICDs have been recalled in the last few years for design and reliability problems. Thermal ablation therapy is an attractive alternative or adjunctive therapy to ICD implantation as it has a success rate of more than 90% for many classes of supraventricular tachycardias, but it has not been successful in treating ischemic VT. It is generally agreed that ablation therapy has been unsuccessful because it is not capable of treating the large, deep arrhythmogenic foci that cause ischemic VT. We have developed a method capable of doing so using saline-enhanced radiofrequency (SERF) ablation. We treat VT by injecting warm saline into the tissue simultaneous with RF ablation. The infused saline flows through the extracellular space convecting energy. This increases the effective thermal conductivity of the tissue by a factor of more than 20. We have used our steerable SERF ablation catheter with a retractable electrode to demonstrate in a canine infarct model that SERF ablation creates thermal lesions large enough to treat VT the lesions are reliably transmural, even in the presence of infarct scars, and multiple lesions can be placed to provide a line of block. We have also shown that the therapy is safe, that the catheter meets safety and reliability requirements, and that it is biocompatible. We propose to complete the development of our saline-enhanced radiofrequency (SERF) ablation system for treating ischemic VT. We will complete the design of our system and catheter and validate that they comply with medical safety standards (EN60601-1), biocompatibility (ISO-10993), and validate the sterilization to a sterility assurance level (SAL) of 10-6. We will carry out extensive preclinical survival testing in large-animal infarct models at the Mayo Clinic, Loyola University, The University of Pennsylvania, and the Brigham and Women's Hospital. We will then apply for and obtain an Investigational Device Exemption (IDE) to carry out a multi-center clinical trial. PUBLIC HEALTH RELEVANCE Our development of SERF ablation to treat ventricular tachycardia (VT) is relevant to public health in that we are addressing a growing and expensive problem the implantable cardioverter defibrillators (ICDs) that patients receive to treat these potentially fatal arrhythmias are neither curative nor reliable. The United States spends over $2B annually placing ICDs, and half of the patients develop additional VTs that are unresponsive to their ICD. At minimum the shocks these patients receive severely reduce their quality of life. At worst the patient remains susceptible to sudden cardiac death. An effective and inexpensive method of treating these patients VTs is urgently needed.

描述（由申请人提供）：美国每年发生的 300,000 例心源性猝死中，一半以上是由缺血性室性心动过速 (VT) 造成的。植入式心律转复除颤器 (ICD) 是标准疗法，但它们价格昂贵，ICD 植入物的总成本接近 50,000 美元，而美国每年在这些植入物上的花费超过 2.2B 美元。 ICD 有效，但无法治愈，接受 ICD 的患者中有一半会出现新部位的 VT，这些部位对除颤器没有反应，需要额外付费服用抗心律失常药物。过去几年，已有 55,000 台 ICD 因设计和可靠性问题被召回。热消融疗法是 ICD 植入的一种有吸引力的替代疗法或辅助疗法，因为它对许多类型的室上性心动过速的成功率超过 90%，但它在治疗缺血性 VT 方面尚未成功。人们普遍认为，消融治疗并不成功，因为它无法治疗导致缺血性室性心动过速的大而深的致心律失常病灶。我们开发了一种能够使用盐水增强射频 (SERF) 消融来实现此目的的方法。我们通过在射频消融的同时将温盐水注射到组织中来治疗VT。注入的盐水流过细胞外空间对流能量。这使组织的有效导热率提高了 20 倍以上。我们使用带有可伸缩电极的可操纵 SERF 消融导管在犬梗塞模型中证明，SERF 消融产生的热损伤足够大，足以治疗 VT。即使存在梗塞疤痕，损伤也能可靠地透壁，并且可以放置多个损伤以提供线阻挡。我们还表明该疗法是安全的，导管满足安全性和可靠性要求，并且具有生物相容性。我们建议完成用于治疗缺血性室性心动过速的盐水增强射频 (SERF) 消融系统的开发。我们将完成系统和导管的设计，并验证它们是否符合医疗安全标准 (EN60601-1)、生物相容性 (ISO-10993)，并验证灭菌是否达到 10-6 的无菌保证水平 (SAL)。我们将在梅奥诊所、洛约拉大学、宾夕法尼亚大学和布莱根妇女医院的大型动物梗塞模型中进行广泛的临床前生存测试。然后我们将申请并获得研究设备豁免（IDE）以进行多中心临床试验。公共健康相关性我们开发用于治疗室性心动过速 (VT) 的 SERF 消融术与公共健康相关，因为我们正在解决一个日益严重且昂贵的问题：患者用于治疗这些潜在致命性心律失常的植入式心律转复除颤器 (ICD) 既无疗效也不可靠。美国每年花费超过 20 亿美元放置 ICD，并且一半的患者出现额外的 VT，而这些 VT 对 ICD 没有反应。至少，这些患者受到的电击严重降低了他们的生活质量。在最坏的情况下，患者仍然容易发生心源性猝死。迫切需要一种有效且廉价的方法来治疗这些患者的室性心动过速。