Novel Catheter for Treatment of Ventricular Tachycardia

治疗室性心动过速的新型导管

• 批准号: 7867928
• 负责人: MICHAEL G CURLEY
• 金额: $ 118.91万
• 依托单位: THERMEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-29 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7867928
• 关键词: 3-Dimensional; Ablation; Acute; Address; Aneurysm; Animal Model; Animals; Anti-Arrhythmia Agents; Arrhythmia; Biocompatible; Canis familiaris; Catheters; Chronic; Cicatrix; Clinic; Clinical; Clinical Research; Clinical Trials; Computer software; Defibrillators; 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; Safety; Saint Jude Children' s Research Hospital; Saline; Shock; Site; Sterility; Sterilization; Supraventricular tachycardia; System; Techniques; Technology; Testing; Thermal Ablation Therapy; Thermal Conductivity; Thrombus; Tissues; Treatment Efficacy; United States; Universities; Validation; Ventricular; Ventricular Arrhythmia; Ventricular Tachycardia; Woman; base; biomaterial compatibility; cost; design; effusion; ergonomics; hemodynamics; implantation; improved; in vivo; meetings; novel; pre-clinical; public health relevance; radiofrequency; safety testing; sensor; soft tissue; success; sudden cardiac death; symposium

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）：缺血性室性心动过速（VT）是美国每年发生的300，000例心脏性猝死中一半以上的原因。植入式心律转复除颤器（ICD）是标准疗法，但它们是昂贵的，ICD植入物的总成本接近5万美元，美国每年在这些植入物上花费超过22亿美元。ICD是有效的，但没有治愈多达一半的接受ICD的患者发展新的VT部位，这些部位对除颤器没有反应，需要他们以额外的费用服用抗心律失常药物。在过去的几年里，有55,000个ICD因设计和可靠性问题被召回。热消融治疗是ICD植入的一种有吸引力的替代或替代治疗，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不成功，因为它不能治疗引起缺血性室性心动过速的大而深的致瘤病灶。我们已经开发出一种能够使用盐水增强射频（SERF）消融来实现这一目标的方法。我们通过在射频消融的同时向组织中注射温盐水来治疗室性心动过速。输注的生理盐水流过细胞外空间对流能量。这将组织的有效导热率提高了20倍以上。我们已经使用了带有可伸缩电极的可操纵SERF消融导管，以在犬梗死模型中证明SERF消融产生的热损伤足够大，可以治疗VT，即使在存在梗死疤痕的情况下，损伤也是可靠的透壁损伤，并且可以放置多个损伤以提供阻滞线。我们还证明了该疗法是安全的，导管符合安全性和可靠性要求，并且具有生物相容性。我们建议完成我们的盐水增强射频（SERF）消融系统治疗缺血性室性心动过速的发展。我们将完成系统和导管的设计，并确认其符合医疗安全标准（EN 60601 -1）、生物相容性（ISO-10993），并确认灭菌达到10-6的无菌保证水平（SAL）。我们将在马约诊所、洛约拉大学、宾夕法尼亚大学和布里格姆妇女医院的大动物梗死模型中进行广泛的临床前生存测试。然后，我们将申请并获得试验用器械豁免（IDE），以开展多中心临床试验。公共卫生相关性我们开发SERF消融治疗室性心动过速（VT）与公共卫生相关，因为我们正在解决一个日益严重且昂贵的问题，即患者接受的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）既不治愈也不可靠。美国每年花费超过20亿美元放置ICD，一半的患者发展出对ICD无反应的额外VT。至少这些患者受到的电击会严重降低他们的生活质量。在最坏的情况下，患者仍然容易发生心脏性猝死。迫切需要一种治疗这些患者VT的有效且廉价的方法。