Implantable Unpinning Termination Therapy for Cardiac Arrhythmias

植入式拔除心律失常终止疗法

• 批准号: 10213278
• 负责人: David W Bourn
• 金额: $ 99.94万
• 依托单位: CARDIALEN, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10213278
• 关键词: Ablation; Acute; Address; Affect; American; Arrhythmia; Atrial Fibrillation; Award; Canis familiaris; Cardiac; Cardiac Electrophysiologic Techniques; Chronic; Cicatrix; Clinical; Clinical Trials; Communities; Consult; Defibrillators; Dementia; Development; Device or Instrument Development; Devices; Doctor of Philosophy; Effectiveness; Electric Countershock; Energy Therapy; Engineering; Ensure; Epidemic; Evaluation; FDA approved; Funding; Future; Generations; Goals; Grant; Healthcare Systems; Heart Atrium; Heart failure; Heterogeneity; Human; Impairment; Individual; Interdisciplinary Study; Intervention; Investigation; Left; Life; Maintenance; Medical; Methods; Microprocessor; Morbidity - disease rate; Nature; Ohio; Pain; Painless; Pathway interactions; Patients; Phase; Physiologic pulse; Progressive Disease; Quality of life; Refractory; Reporting; Secure; Shock; Sinus; Small Business Innovation Research Grant; Specific qualifier value; Stroke; Symptoms; System; Systems Development; Tachyarrhythmias; Tachycardia; Telemetry; Testing; Thromboembolism; Tissues; United States National Institutes of Health; Ventricular; Ventricular Arrhythmia; Ventricular Fibrillation; Ventricular Tachycardia; Washington; base; clinical practice; cost; exercise capacity; experience; falls; first-in-human; heart function; heart rhythm; hemodynamics; implantable device; improved; innovation; mortality; novel; novel therapeutics; prevent; prototype; research and development; safety and feasibility; stroke risk; sudden cardiac death; therapy development; translational study; treatment risk; voltage

Project Summary/Abstract We propose the development and evaluation of a novel implantable low-energy device, using an innovative low-energy multi-pulse therapy, to achieve well-tolerated treatment of ventricular and atrial tachyarrhythmias. Ventricular arrhythmias (VAs) including ventricular tachycardia (VT) and ventricular fibrillation (VF) are responsible for 75-80% of Sudden Cardiac Death (SCD) cases. Sudden cardiac death kills nearly 450,000 Americans yearly. In the majority of these patients, the most common initial arrhythmia is sustained VT which can degrade into VF. A high-energy biphasic shock delivered by an implantable cardiac defibrillator (ICD) is the only existing therapy to terminate VA when low-energy anti-tachycardia pacing fails. These high energy shocks are associated with increased mortality and severe pain. Similarly, atrial fibrillation (AF), an atrial tachyarrhythmia, is a global epidemic. Approximately 33.5 million individuals are affected worldwide and close to 5 million new cases occur each year costing the US healthcare system between $6 and $26 billion annually. AF is a progressive disease with many patients first developing paroxysmal atrial fibrillation (PAF). Left untreated, PAF can progress to persistent or permanent AF. Because of rapid changes in the atria after AF onset, a therapy to treat AF soon after onset may slow the progressive nature of AF. There exists great enthusiasm in the medical community for AF interventions due to the limited efficacy of current treatments and risks to the patients. An effective atrial defibrillator was previously developed; however, it was abandoned due to pain associated with shocks and rapid battery depletion as a high number of high-energy shocks had to be delivered. A well-tolerated, low-energy, device-based VA and AF therapy without high-energy shocks would address a major unmet medical need. Prior canine and early stage acute human studies with a non- implantable version of the proposed system have observed that the proposed therapy approach significantly lowers the energy required for effective VT and AF therapy into ranges that have been reported as tolerated by patients. The goal of this proposed phase IIB project is to develop and test a fully implantable prototype low- energy therapy device for use in future chronic human studies under IDE exemption involving treatment of VT and AF.

项目摘要/摘要 我们提出了使用创新的新型可植入式低能设备的开发和评估 低能多脉冲疗法，以实现心室和心律不齐的耐受性疗法。 心室心律不齐（VAS），包括心室心动过速（VT）和心室纤颤（VF） 负责75-80％的心脏死亡（SCD）病例。猝死杀死了近45万 美国人一年。在大多数这些患者中，最常见的初始心律不齐是持续的VT 可以退化为VF。由可植入的心脏除颤器（ICD）传递的高能双相冲击是 只有在低能量抗心动节奏起搏的情况下才能终止VA的现有疗法。这些高能量 冲击与死亡率增加和剧烈疼痛有关。同样，心房颤动（AF），心房 Tachyarrhythmia是一种全球流行病。大约有3350万人在全球受到影响并关闭 每年发生500万个新病例，每年耗费美国医疗保健系统6至260亿美元。 AF是一种进行性疾病，许多患者首先开发阵发性心房颤动（PAF）。左边 未经治疗的PAF可以持续或永久性AF进行。由于AF之后心房的迅速变化 发作的疗法在发作后不久治疗AF可能会减慢AF的进步性质。存在很棒 由于当前治疗的功效有限，医学界对AF干预的热情和 对患者有风险。先前开发了有效的心房除颤器。但是，它被放弃了 由于大量的高能冲击必须是与冲击和快速电池耗尽相关的疼痛 发表。具有高耐受性，低能，基于设备的VA和AF疗法，没有高能量冲击 解决了主要的未满足医疗需求。前犬和早期急性人类研究 拟议系统的可植入版本观察到拟议的治疗方法明显 将有效VT和AF治疗所需的能量降低到已据报道的范围 患者。该提出的IIB期项目的目的是开发和测试一个完全可植入的原型低 - 能源治疗手段用于未来的慢性人类研究，涉及VT治疗的IDE豁免 和AF。