Spatial Resynchronization Therapy for AFib

AFib 空间再同步治疗

基本信息

批准号：
10546248
负责人：
Graydon Ernest Beatty
金额：
$ 29.94万
依托单位：
MAXWELL BIOMEDICAL INC
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-15 至 2023-09-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10546248
关键词：
Ablation Acute Address Adopted Adult Affect Algorithmic Analysis Algorithms Anesthesia procedures Anti-Arrhythmia Agents Arrhythmia Atrial Fibrillation Cardiac Cardiac ablation Cardiovascular system Caring Cessation of life Chest Cicatrix Clinical Clinical Research Complex Computer Simulation Consumption Data Defibrillators Development Devices Direct Costs Disease Economic Burden Effectiveness Electric Countershock Electrodes Epicardium Event Feedback Freezing Future Harvest Healthcare Systems Heart Atrium Heart failure Hospitalization Impaired cognition Implant Incidence Infection Institutes Left Left atrial structure Legal patent Location Methods National Heart, Lung, and Blood Institute Pain Pain Threshold Pathway interactions Patients Pattern Persons Pharmaceutical Preparations Pharmacology Phase Physiologic pulse Physiological Play Positioning Attribute Power Sources Prevalence Procedures Process Progressive Disease Quality of life Records Refractory Reporting Risk Role Sedation procedure Shock Signal Transduction Silicon Site Stroke Survival Rate System Systems Theory Technology Testing TimeLine Tissues United States National Institutes of Health base clinical application commercialization common treatment cost cost estimate design dynamic system efficacy evaluation efficacy validation flexibility functional status hazard heart rhythm high risk implantable device in vivo mortality novel patient population phase 1 study porcine model relating to nervous system response sensor spatiotemporal standard of care stroke risk success technology/technique therapy design treatment strategy trend voltage wireless

项目摘要

ABSTRACT More than 450,000 hospitalizations each year in the US are due to atrial fibrillation (AF) which contributes to approximately 160,000 deaths. This trend has been increasing for more than two decades, with estimations that 12.1 million people in the US will have AF by 2030, placing a significant burden on the healthcare system. Complications of AF include stroke, heart failure, and increasing mortality. AF is a progressive disease with catheter ablation becoming increasingly common for the treatment of AF despite limited and highly variable success rates and complications, with arrhythmia-free survival rates < 29% at 5 years. The current acute standard of care is external cardioversion, with or without antiarrhythmic drugs. Unfortunately, high-voltage external shocks are extremely painful, can cause additional arrhythmias, and often require escalation of care at an annual cost of ~$26 billion. Efforts to address this unmet need have focused on internal atrial cardioversion which has not been widely adopted due to the invasiveness and intolerable pain suffered from shocks. Efforts to overcome these limitations have focused on wireless implantable devices which have been hindered by high power consumption attributable to power harvesting modules of the circuit design. The Maxwell Biomedical Spatial Resynchronization Therapy (SRT) System resolves the limitations of wireless implantable technologies and high energy cardioversion for treating AF by utilizing spatiotemporal identification and stimulation to globally advance refractoriness of complex reentry patterns enabling imperceptible pace-termination of AF. This is accomplished via the SATELLITETM epicardial implant device, which is a wirelessly powered flexible circuit with multiple paired electrodes that, when implanted, are distributed across the posterior wall of the left atrium. The system records cardiac electrograms from each of the electrodes and the algorithm analyzes these signals to determine electronic selection and pacing of paired electrodes using a state-of-the-art method from Dynamical System Theory. Importantly, it operates below 0.1 J, an order of magnitude below the threshold for pain. Evidence for the effectiveness of this approach has been shown in bench and in vivo studies, where the SATELLITETM silicon CMOS components and sensors demonstrated a power transfer efficiency of 68%, far exceeding current wirelessly powered devices. The ability of the algorithm to identify and pace-terminate AF has also been confirmed in an open chest swine model of AF, which supports the translatability of SRT. The Maxwell Biomedical SRT System is now ready for final refinement of the algorithm and implant hardware to achieve design freeze, which will be characterized first on the bench (Aim 1), followed by the assessment of efficacy and deliverability in vivo (Aim 2). Successful execution of Phase I studies will position SRT System for full development, clinical studies, regulatory approval (future Phase II), and commercialization of a highly disruptive technology to treat the growing population of patients with AF.

抽象的在美国，每年有超过 450,000 例患者因心房颤动 (AF) 住院，这导致约16万人死亡。二十多年来，这种趋势一直在增加，据估计到 2030 年，美国将有 1210 万人患有房颤，这给医疗保健系统带来沉重负担。房颤的并发症包括中风、心力衰竭和死亡率增加。 AF 是一种进行性疾病尽管有限且变化很大，导管消融在治疗 AF 中变得越来越普遍成功率和并发症，5 年无心律失常生存率 < 29%。目前急性标准护理是外部心脏复律，使用或不使用抗心律失常药物。不幸的是，高压外部冲击非常痛苦，可能导致额外的心律失常，并且通常需要升级护理每年的成本约为 260 亿美元。解决这一未满足的需求的努力集中在心房复律上由于电击的侵入性和难以忍受的疼痛，尚未被广泛采用。努力为了克服这些限制，人们将注意力集中在无线植入设备上，但这些设备一直受到高功耗归因于电路设计的能量收集模块。麦克斯韦生物医学空间再同步治疗（SRT）系统解决了无线植入技术的局限性和高能量心脏复律，通过利用时空识别和刺激来治疗 AF 全球范围内提高了复杂折返模式的难治性，从而实现了难以察觉的房颤起搏终止。这是通过 SATELLITETM 心外膜植入设备实现的，该设备是一种无线供电的灵活的具有多个成对电极的电路，植入后分布在左侧后壁上中庭。系统记录每个电极的心电图，并由算法分析这些心电图使用最先进的方法确定成对电极的电子选择和起搏信号动力系统理论。重要的是，它的运行温度低于 0.1 J，比阈值低一个数量级疼痛。这种方法有效性的证据已在实验室和体内研究中得到证明，其中 SATELLITETM 硅 CMOS 元件和传感器的功率传输效率达到 68%，远超预期。超过当前的无线供电设备。算法识别和终止 AF 的能力在 AF 的开胸猪模型中也得到了证实，该模型支持 SRT 的可翻译性。这 Maxwell 生物医学 SRT 系统现已准备好对算法和植入硬件进行最终完善，以实现设计冻结，首先在工作台上进行表征（目标 1），然后评估体内功效和递送能力（目标 2）。第一阶段研究的成功执行将使 SRT 系统定位于全面开发、临床研究、监管批准（未来的第二阶段）和高度商业化颠覆性技术来治疗不断增长的 AF 患者群体。