权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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.

项目总结