Painless Defibrillation

无痛除颤

基本信息

批准号：
9920774
负责人：
Howard Levin
金额：
$ 98.26万
依托单位：
CORIDEA, LLC
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-04-01 至 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9920774
关键词：
Abdomen Abdominal Muscles Acceleration Accelerometer Animals Arrhythmia Blinded Chest Chest wall structure Civilization Clinical Clinical Research Conscious Conscious Sedation Contracts Defibrillators Development Device Designs Device or Instrument Development Devices Electric Countershock Esthesia Exposure to Family suidae Feedback Forelimb Frequencies Funding Goals Grant Heart Heart Arrest Human Implant Implantable Defibrillators Infrastructure Investigation Investments Lead Life Manufacturer Name Mediating Medical Device Methodology Methods Modeling Motion Pain Pain Measurement Painless Patients Phase Pilot Projects Preparation Protocols documentation Reporting Risk Safety Savings Sedation procedure Series Shock Skeletal Muscle Small Business Innovation Research Grant Sterility System Technology Testing Ventricular Fibrillation Work arm base clinical investigation design efficacy testing electric field experience first-in-human heart rhythm hemodynamics implantable device instrument interest meetings novel novel therapeutics prototype response safety testing verification and validation voltage

项目摘要

Project Summary The purpose of the proposed work is first-in-man testing of novel painless defibrillation (PaDe) therapy. Sudden cardiac arrest (SCA) remains the number one killer in western civilization. The underlying mechanism of SCA is usually ventricular fibrillation (VF), and survival depends on prompt defibrillation. Existing defibrillators rely on the delivery of a brief high voltage shock to the heart. While this is life-saving, the shock is extremely painful when delivered to a conscious patient, as typically happens when the therapy is provided by an ICD. The pain caused by standard ICD shocks is due to the abrupt contraction of skeletal muscles of the chest and abdomen when the shock is applied to the heart. Our team has developed a novel means to accomplish painless defibrillation using a burst of high frequency alternating current to tetanize skeletal muscle so it does not further contract when a defibrillatory shock is then applied. We have already proven substantial reduction in skeletal muscle activation in animals defibrillated using this technology, and therefore believe that delivery of this novel therapy in humans will be a far less painful alternative to standard defibrillation shocks. In the proposed work, a table-top PaDe system developed in our Phase II grant will undergo final verification and validation testing needed to obtain FDA approval of an IDE, which will then enable us to evaluate this therapy in patients coming for elective ICD replacement. Patients will receive one PaDe therapy and one standard shock in random order, and will report the pain perceived with each of these, blinded to which is which. We intend to show that PaDe therapy is safe and effective, and will then seek FDA approval of the therapy.

项目概要拟议工作的目的是对新型无痛除颤进行首次人体测试（帕德）疗法。心脏骤停（SCA）仍然是西方国家的头号杀手文明。 SCA 的潜在机制通常是心室颤动 (VF)，并且生存取决于及时除颤。现有的除颤器依赖于提供短暂的高电压震撼心灵。虽然这可以挽救生命，但电击给患者带来极大痛苦。意识清醒的患者，这通常发生在由 ICD 提供治疗时。标准 ICD 电击引起的疼痛是由于骨骼肌突然收缩造成的当心脏受到电击时，胸部和腹部会受到影响。我们的团队开发了一个使用高频交替脉冲实现无痛除颤的新颖方法电流使骨骼肌强直，使其在除颤电击时不会进一步收缩然后应用。我们已经证明骨骼肌激活显着减少动物使用这种技术进行除颤，因此相信这种新型疗法的实施对于人类来说，这将是比标准除颤电击痛苦得多的替代方案。在拟议的工作中，我们第二阶段拨款中开发的桌面 PaDe 系统将进行获得 FDA 对 IDE 的批准所需的最终验证和验证测试，然后将使我们能够在择期更换 ICD 的患者中评估这种疗法。患者会按随机顺序接受一次 PaDe 治疗和一次标准电击，并将报告疼痛情况对这些中的每一个都进行感知，对哪个是哪个都视而不见。我们打算证明 PaDe 疗法是安全有效，然后将寻求 FDA 批准该疗法。