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

• 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
• 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' 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

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 在美国，房颤（AF）的患病率估计为总人口的1%。 States.令人震惊的是，30%至60%（根据研究）的房颤患者不知道他们的 诊断（无症状房颤）。大多数AF患者将患有充血性心力衰竭或/和发展 血栓栓塞事件导致患者生活质量显著降低， 医疗资源的巨大消耗。因此，AF预防代表了以下因素之一： 现代临床心脏病学最重大的挑战。在拟议项目中，我们将 评估一个新的概念，病人监测利用家庭为基础的设备称为“心， 垫”。我们会进行第一阶段的工作，设计仪器的原型，并在 20例AF患者的小型队列。然后，我们建议围绕临床研究开展第二阶段项目。 在这项研究中，我们将招募280名接受射频消融或 电复律和监测这些患者在家里使用心电图补丁和 提出了新技术。我们将在手术后14天内对这些患者进行随访。 该研究的主要目标是评估拟议的家用设备是否能够可靠地 检测AF的存在，并以适当的及时方式。