Painless Defibrillation

无痛除颤

• 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
• 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

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.

项目摘要 拟议工作的目的是对新型无痛除颤的首次测试 （Pade）治疗。突然心脏骤停（SCA）仍然是西部的第一杀手 文明。 SCA的潜在机制通常是心室纤颤（VF）和存活 取决于及时的除颤。现有的除颤器依赖于短暂的高电压的交付 震惊心脏。虽然这是挽救生命的，但是当送到一个 有意识的患者，正如ICD提供治疗时通常发生的那样。 标准ICD冲击引起的疼痛是由于骨骼肌突然收缩 当冲击施加到心脏时，胸部和腹部。我们的团队已经开发了 新颖的手段，可以使用高频交替爆发来完成无痛的除颤 电流以破坏骨骼肌，因此当除颤性冲击是 然后应用。我们已经证明了骨骼肌激活的大幅减少 动物使用这项技术进行除颤，因此相信这种新型疗法的提供 在人类中，对于标准除颤冲击而言，将是痛苦的替代品。 在拟议的工作中，我们的第二阶段赠款中开发了一个桌面幻觉系统 获得IDE的FDA批准所需的最终验证和验证测试，然后将 使我们能够评估该疗法的患者，以进行选择性ICD替代。患者会 随机收到一种幻影治疗和一项标准冲击，并将报告疼痛 对每一个都感知到了，这是蒙蔽的。我们打算表明pade疗法是 安全有效，然后寻求FDA批准该疗法。