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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.

摘要