Painless Defibrillation

项目摘要 这项拟议的工作的目的是对新型无痛除颤进行第一次面对面测试 (PADE)疗法。心脏骤停(SCA)仍然是西部地区的头号杀手 文明。SCA的潜在机制通常是室颤(VF)和存活率 取决于迅速的除颤。现有的除颤器依赖于提供短暂的高压 震撼了心脏。虽然这是拯救生命的，但当电击传到 意识清醒的患者，当治疗由ICD提供时通常会发生。 标准的ICD电击引起的疼痛是由于骨骼肌的突然收缩。 当电击作用于心脏时，胸部和腹部的变化。我们的团队已经开发出一种 使用高频交变脉冲实现无痛除颤的新方法 电流使骨骼肌强直，这样除颤性休克时就不会进一步收缩 然后申请了。我们已经证明骨骼肌的激活在 动物使用这种技术进行除颤，因此认为这种新疗法的交付 与标准的除颤电击相比，人体电击将是一种痛苦得多的替代方案。 在拟议的工作中，在我们的第二阶段赠款中开发的桌面Pade系统将经历 获得FDA批准的IDE所需的最终验证和验证测试，然后 使我们能够在来进行选择性ICD置换术的患者中评估这种疗法。患者会 随机顺序接受一次Pade疗法和一次标准电击，并将报告疼痛 用每一种感觉，盲目地看不到哪一种是哪种。我们打算证明佩德疗法是 安全有效，然后将寻求FDA批准该疗法。

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.