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

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
4R42NR018316-02
Application #
9950620
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Bough, Kristopher J
Project Start
2018-07-06
Project End
2021-07-31
Budget Start
2019-09-24
Budget End
2020-07-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Global Instrumentation, LLC
Department
Type
DUNS #
147035427
City
Manlius
State
NY
Country
United States
Zip Code
13104