Novel Therapy System for Atrial Fibrillation

心房颤动的新型治疗系统

基本信息

批准号：
10252060
负责人：
Jeffrey Peters
金额：
$ 52.7万
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 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10252060
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方法，以实现可忍受的，几乎无疼痛的房颤治疗。心房颤动（AF）是全球流行病。在全球范围内约有3350万人受到影响，接近500万个新人每年发生的案件每年耗资美国医疗保健系统6至260亿美元。心房颤动是一种进行性疾病，许多患者首先开发阵发性心房颤动（PAF）。不加治疗， PAF可以持续或永久性AF进行。由于AF发作后心房的快速变化，发作后不久治疗AF的治疗可能会减慢心房颤动的渐进性。存在很棒医学界对AF干预的热情。药理学和其他基于设备的治疗AF的努力令人失望。以前是有效的心房除颤器发达;但是，由于与冲击有关的疼痛，它被放弃了。一个可容忍的，几乎没有疼痛，基于设备的AF治疗方法将满足主要未满足的医疗需求。前犬和早期阶段人类研究已经观察到，拟议的治疗方法显着降低了所需的能量心房除颤。该提议直接进行II期项目的目的是开发原型AF疗法设备并在FDA IDE下的人类临床试验中评估其性能。