Wireless Vagal Nerve Stimulation System for Treating Atrial Fibrillation

用于治疗心房颤动的无线迷走神经刺激系统

• 批准号: 8918091
• 负责人: Austin Robert Duke
• 金额: $ 2.5万
• 依托单位: ROSELLINI SCIENTIFIC, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-21 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8918091
• 关键词: Accounting; Acute; Affect; Aging; American; Animals; Arrhythmia; Atrial Fibrillation; Autonomic nervous system; Biomedical Engineering; Canis familiaris; Cardiac; Cessation of life; Chronic; Computational Biology; Control Groups; Development; Device or Instrument Development; Devices; Doctor of Philosophy; Electric Stimulation; Electrodes; Electronics; Frequencies; Funding; Goals; Health; Healthcare Systems; Heart Atrium; Heart Rate; Hour; Human Resources; Implant; Individual; Intervention; Ischemic Stroke; Left; Legal patent; Longitudinal Studies; Medical Device; Medicare; Methods; Metric; Modality; Modeling; Morbidity - disease rate; Multi-Institutional Clinical Trial; Myocardium; Nerve; Neuromodulator; Neurosciences; Neurostimulation procedures of spinal cord tissue; Pathology; Pharmaceutical Preparations; Phase; Physiologic pulse; Population; Procedures; Publishing; Quality of life; Recurrence; Research; Risk; Risk Factors; Societies; Stroke; Sum; System; Techniques; Technology; Testing; Therapeutic; Tinnitus; Translating; Treatment Protocols; United States National Institutes of Health; Vagus nerve structure; Wireless Technology; auricular appendage; austin; clinical application; cost; implantable device; innovation; mortality; nervous system disorder; neuroregulation; neurotechnology; novel; pre-clinical; relating to nervous system; vagus nerve stimulation

DESCRIPTION (provided by applicant): Atrial fibrillation (AF) is the most common cardiac arrhythmia, and is associated with substantial risk of morbidity and mortality. AF currently affects more than 2.5 million Americans and the affected population is steadily growing with our aging society. AF independently increases the risk of stroke by 4- to 5-fold, is an independent risk factor for stroke recurrence, and is responsible for at least 15-20% of all ischemic strokes. In addition to its associated health risks and diminished quality of life, AF is a financial burden on the US Healthcare system, with annual Medicare costs currently estimated at $16 billion. Over the past decade, neuromodulator emerged as an alternative to antiarrhythmic medications and ablative procedures for the treatment of some forms of AF. Applying low levels of electrical stimulation to the vagus nerves inhibits AF inducibility. This innovative form of neural cardiac control is a non-pharmacological, non- ablative modality for the treatment of AF that maintains healthy myocardium. The ultimate goal of this project is to enhance the quality of life for individuals with AF by translating this recent cutting edge research into a clinically viable technology. To date the majority of studies investigating neuromodulation as a treatment for AF were acute procedures. To progress this approach towards clinical application will require the development of suitable devices capable of chronic stimulation. Rosellini Scientific has partnered with Stimwave Technologies Inc. to apply their wireless spinal cord stimulation technology to a form factor and therapeutic treatment protocol suitable for low-level vagus nerve stimulation (LL-VNS) to treat AF. The goal of the proposed study is to evaluate the therapeutic value of LL- VNS for treating AF in a long-term study. To accomplish this goal, we will implant our system in a high-yield canine model of AF and evaluate changes in AF frequency as a result of LL-VNS for a period of 4 weeks. During the experimental period, an implantable pulse generator (IPG) will deliver rapid atrial pacing (RAP) to the left atrial appendage for 6 hours/day to induce AF. Concurrent with RAP, the experimental group will receive LL-VNS from the Rosellini Scientific VNS system, while the control group will receive sham stimulation. The weekly AF burden, defined as the sum of the duration of all spontaneous AF episodes during the period without RAP, will be calculated and compared between groups. For our treatment to be indicated as feasible, we must see e 50% reduction in AF burden for the treatment group versus control. If feasibility is achieved, we will apply to the NIH for Phase 2 funding to determine the appropriate treatment protocol in a chronic study and will submit a U44 to further develop the device.

描述(申请人提供)：房颤(房颤)是最常见的心律失常，与发病率和死亡率的巨大风险有关。房颤目前影响着超过250万美国人，而且随着我们的老龄化社会，受影响的人口正在稳步增长。房颤使卒中风险增加4-5倍，是卒中复发的独立危险因素，至少占所有缺血性卒中的15%-20%。除了相关的健康风险和生活质量下降外，房颤还是一种经济负担 在美国医疗保健系统，每年的医疗保险成本目前估计为160亿美元。在过去的十年中，神经调节剂作为抗心律失常药物和消融术的替代药物出现，用于治疗某些形式的房颤。对迷走神经施加低水平的电刺激可抑制房颤的诱发。这种神经心脏控制的创新形式是一种非药物、非消融的治疗房颤的方法，可以维持健康的心肌。该项目的最终目标是通过将最近的尖端研究转化为临床可行的技术来提高房颤患者的生活质量。到目前为止，研究神经调节作为房颤治疗方法的大多数研究都是急性手术。要将这一方法推向临床应用，将需要开发能够长期刺激的合适设备。Rosellini Science与Stimwave Technologies Inc.合作，将他们的无线脊髓刺激技术应用于一种适用于低水平迷走神经刺激(LL-VNS)治疗房颤的外形因素和治疗方案。这项拟议研究的目的是在一项长期研究中评估LL-VNS治疗房颤的治疗价值。为了实现这一目标，我们将把我们的系统植入一个高产量的房颤犬模型中，并评估作为LL-VNS结果的房颤频率的变化，为期4周。在实验期间，植入式脉冲发生器(Ipg)将向左心耳提供6小时/天的快速心房起搏(Rap)。 诱发房颤。在RAP的同时，实验组将接受Rosellini Science VNS系统的LL-VNS，而对照组将接受假刺激。每周的房颤负荷，定义为在没有RAP期间所有自发房颤发作的持续时间的总和，将被计算并在不同组之间进行比较。为了证明我们的治疗是可行的，我们必须看到与对照组相比，治疗组的房颤负担减少了50%。如果可行，我们将向NIH申请第二阶段资金，以确定适合慢性研究的治疗方案，并将提交U44以进一步开发该设备。