Novel Home-Based and Low-Cost ECG Device for periodic evaluation of the presence of atrial fibrillation

用于定期评估心房颤动是否存在的新型家用低成本心电图设备

基本信息

批准号：
9554334
负责人：
JEAN-PHILIPPE Y COUDERC
金额：
$ 13.65万
依托单位：
GLOBAL INSTRUMENTATION, LLC
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-06 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9554334
关键词：
AF2 Ablation Affect Aging Anticoagulation Arrhythmia Atrial Fibrillation Blood flow Cardiology Cardiovascular system Clinical Clinical Research Complement Computer software Congestive Heart Failure Consumption Data Set Detection Devices Diagnosis Diagnostic Disease Early Diagnosis Electric Countershock Electrocardiogram Enrollment Evaluation Event General Population Goals Gold Health Healthcare Heart Rate Home environment Hospitalization Hospitals Hour Individual Lead Limb structure Measurement Measures Modernization Monitor Oxygen Patient Monitoring Patients Performance Periodicity Phase Physicians Physicians&apos Offices Prevalence Prevention Probability Procedures Process Quality of life Radiofrequency Interstitial Ablation Recurrence Resources Risk Factors Secondary to Sensitivity and Specificity Shock Signal Transduction Sinus Specificity Stroke Symptoms Technology Testing Time United States Validation Weight base blood flow measurement burden of illness clinical practice cohort cost cost efficient design follow-up health care service utilization health economics heart electrical activity heart rhythm improved mortality new technology novel programs prototype self-directed learning sensor

项目摘要

Abstract Atrial fibrillation (AF) prevalence is estimated to 1% of the general population in the United States. A shocking 30% to 60% (according to studies) of patients with AF are unaware of their diagnosis (silent AF). Most AF patients will suffer from congestive heart failure or/and develop thromboembolic events leading to a dramatic reduction of patients’ quality of life, and a significant consumption of health care resources. Therefore, AF prevention represents one of the most significant challenges of modern clinical cardiology. In the proposed project, we will evaluate a novel concept of patient monitoring utilizing a home-based device called the “Cardio- Mat”. We will conduct a Phase 1 to design the prototype of the device and test the device in a small cohort of 20 AF patients. Then, we propose to conduct a Phase 2 project around a clinical study in which we will enroll 280 AF patients going through either radiofrequency ablation or electrical cardioversion and monitor these patients at home using an ECG patch and the proposed new technology. We will follow these patients during 14 days after their procedure. The primary goal of the study is to evaluate whether the proposed home device can reliably detect the presence of AF and in an appropriate timely fashion.

抽象的心房颤动（AF）患病率估计为联合的总人群的1％国家。令人震惊的30％至60％（根据研究）不知道自己的AF患者诊断（无声AF）。大多数AF患者会患有充血性心力衰竭或/并发展血栓栓塞事件，导致患者的生活质量大大降低，并且大量消费卫生保健资源。因此，预防AF代表现代临床心脏病学的最重要挑战。在拟议的项目中，我们将评估一种新颖的患者监测的概念，该概念使用一种名为“ Cardio-的家庭设备垫子”。我们将进行1阶段1来设计设备的原型并在A中测试设备小组的20名AF患者。然后，我们建议在临床上进行2期项目我们将在其中注册280名通过射频消融或电动心脏扭转并使用ECG补丁和拟议的新技术。我们将在这些患者手术后的14天内关注这些患者。该研究的主要目标是评估提议的家庭装置是否可以可靠以适当的方式检测AF的存在。