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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42NR018316-02
Agency Tracking Number: R42NR018316
Amount: $891,205.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 600
Solicitation Number: PA17-303
Timeline
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-24
Award End Date (Contract End Date): 2021-07-31
Small Business Information
8104 CAZENOVIA RD STE 2/3
Manlius, NY 13104-6700
United States
DUNS: 147035427
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 JEANPHILIPPE COUDERC
 (585) 275-5391
 jean-philippe.couderc@heart.rochester.edu
Business Contact
 JIM DEMASO
Phone: (315) 682-0272
Email: jimdemaso@msn.com
Research Institution
 UNIVERSITY OF ROCHESTER
 
518 Hylan Building, Box 270140
ROCHESTER, NY 14627-0140
United States

 Nonprofit college or university
Abstract

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.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.

* Information listed above is at the time of submission. *

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