SBIR-STTR Award

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.

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

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.

Public Health Relevance Statement:


Project narrative:
Atrial fibrillation (AF) prevalence is estimated to 1% of the general population in the United States. A shocking ~40% of patients with AF are unaware of their diagnosis therefore, we plan to develop a novel technology enabling home-based monitoring of the electrical activity of the heart for detecting the presence of AF.

NIH Spending Category:
Behavioral and Social Science; Bioengineering; Cardiovascular; Clinical Research; Heart Disease

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