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 这项工作的目的是对新型无痛除颤器进行首次人体试验 （PaDe）therapy.心脏骤停仍然是西部地区的头号杀手 文明SCA的潜在机制通常是心室颤动（VF）， 取决于及时的除颤现有的整流器依赖于短暂的高电压的输送， 电击心脏虽然这是挽救生命的，但当传递到一个 清醒的患者，如由ICD提供治疗时通常发生的。 标准ICD电击引起的疼痛是由于骨骼肌的突然收缩 心脏受到电击时胸部和腹部的疼痛我们的团队开发了一个 使用高频交变脉冲串实现无痛除颤的新方法 电流使骨骼肌强直，使其在急性休克时不再进一步收缩。 然后应用。我们已经证明，在骨骼肌激活的实质性减少， 使用这种技术去纤颤的动物，因此相信这种新疗法的递送 将是一种比标准除颤电击痛苦小得多的选择。 在拟议的工作中，我们在第二阶段赠款中开发的桌面PaDe系统将进行 获得FDA批准IDE所需的最终验证和确认测试，然后 使我们能够评估这种治疗在择期ICD置换患者中的效果。患者将 随机接受一次PaDe治疗和一次标准电击，并报告疼痛 每一个人，都有自己的一面，都有自己的一面。我们打算证明PaDe疗法 安全有效，然后将寻求FDA批准该疗法。