Novel Therapy System for Atrial Fibrillation

心房颤动的新型治疗系统

基本信息

批准号：
10081026
负责人：
David W Bourn
金额：
$ 160.54万
依托单位：
CARDIALEN, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-02 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10081026
关键词：
Ablation Address Adoption Affect Age-Years American Arrhythmia Atrial Fibrillation Biomedical Engineering Body Surface Canis familiaris Cardiac Cardiac Electrophysiologic Techniques Cardiac ablation Cicatrix Clinical Clinical Trials Clinical effectiveness Collaborations Communities Computer software Consult Custom Data Defibrillators Dementia Department chair Development Devices Doctor of Philosophy Effectiveness Elderly Electric Countershock Epidemic Evaluation FDA approved Freedom Goals Healthcare Systems Heart Heart Atrium Heterogeneity Hospitals Human Impairment Implantable Defibrillators Individual Interdisciplinary Study Intervention Investigation Laboratories Left Maintenance Medical Methods Nature Ohio Pain Pain-Free Painless Pathway interactions Patient Care Patients Performance Pharmacology Phase Physiologic pulse Procedures Progressive Disease Quality of life Research Personnel Risk Safety Sedation procedure Shock Sinus Specific qualifier value Stroke Symptoms System Testing Thromboembolism Tissues Universities Washington Woman base clinical practice cost effective therapy exercise capacity falls first-in-human heart function implantable device improved innovation lifetime risk men mortality novel novel therapeutics prevent prototype research and development safety and feasibility therapy development translational study voltage

项目摘要

Project Summary/Abstract We propose the development and evaluation of a novel implantable low-energy device, using an innovative low-energy approach, to achieve tolerable, nearly pain free treatment of atrial fibrillation. Atrial fibrillation (AF) 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. Atrial fibrillation 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 atrial fibrillation. There exists great enthusiasm in the medical community for AF interventions. Limitations in both pharmacologic and other device-based efforts to treat AF have been disappointing. An effective atrial defibrillator was previously developed; however, it was abandoned due to pain associated with shocks. A tolerable, nearly pain-free, device-based AF therapy approach would address a major unmet medical need. Prior canine and early stage human studies have observed that the proposed therapy approach significantly lowers the energy required for atrial defibrillation. The goal of this proposed direct to phase II project is to develop a prototype AF therapy device and evaluate its performance in a human clinical trial under FDA IDE.

项目概要/摘要我们建议使用创新的方法开发和评估一种新型植入式低能量设备低能量的方法，实现可耐受、近乎无痛的房颤治疗。心房颤动 (AF) 是一种全球流行病。全球约有 3,350 万人受到影响，新增近 500 万人受到影响每年都会发生此类病例，每年给美国医疗保健系统造成 6 至 260 亿美元的损失。心房颤动是一种进行性疾病，许多患者首先出现阵发性心房颤动 (PAF)。未经治疗， PAF 可进展为持续性或永久性 AF。由于房颤发生后心房发生快速变化，房颤发作后立即进行治疗可能会减缓房颤的进展。存在着伟大的医学界对房颤干预的热情。药理学和其他方面的局限性基于设备的治疗 AF 的努力令人失望。以前有一种有效的心房除颤器发达;然而，由于电击带来的疼痛，它被放弃了。可以忍受，几乎无痛，基于设备的 AF 治疗方法将解决主要的未满足的医疗需求。前期犬科和早期阶段人类研究发现，所提出的治疗方法显着降低了所需的能量心房除颤。该直接进入 II 期项目的目标是开发一种原型 AF 疗法设备并在 FDA IDE 下的人体临床试验中评估其性能。