PROJECT ABSTRACT
This research aims to improve cardiovascular outcomes and quality of life for atrial fibrillation (AF) patients by
allowing them to antiarrhythmic drugs (AADs) safely at home. AF is the most common heart rhythm disorder,
affecting more than 38 million worldwide and causing significant morbidity and mortality. AADs reduce mortality
unlike other AF medications, but access to many is restricted by a three-day hospitalization required to start
these oral medications. This is due to a rare (<0.6%) heart rhythm side effect that may require defibrillation and
can be avoided by heart rhythm analysis. During a “drug load” hospitalization, corrected QT (QTc) intervals
from patient electrocardiograms (ECGs) are manually measured and tracked, as changes in the QTc interval
predicts adverse responses to AADs. For AF patients at low risk of proarrhythmia, the cost and risks of
hospitalization may outweigh the benefits. Importantly, for minority and rural populations where access to
elective hospitalization is limited, there is underutilization of guideline-based AF therapy and higher mortality.
The goal of this proposal is to develop a SafeBeat Kit that combines commercially available products (mobile
ECG device, mobile cardiac telemetry, and wearable defibrillator), with proprietary software that allows patients
to start AADs safely at home. In Phase-I equivalent studies, SafeBeat Rx developed the first machine learning
(ML) algorithm to automate QTc measurements from 12-lead and mobile 6-lead ECGs. The high QTc accuracy
(5±7 ms) enabled the algorithm to recommend AAD dosing with 90% accuracy compared to physicians. These
successful results have proven feasibility for the algorithm to support outpatient drug loading and ultimately
replace the three-day hospitalization. Results have also enabled us to submit an FDA 510(k) application for
approval of the QTc algorithm, which is currently underway. Our Phase II proposal is a human study validating
the SafeBeat Rx algorithm on the intended use population: AF patients starting AADs. During inpatient “drug
load” admissions, we will provide patients with commercially available devices approved for home use and
compare SafeBeat software QTc measurements and AAD dosing recommendations to real-time decisions
made by the expert medical team. This technology will improve our ability to deliver standard of care AF
treatment at home safely via remote patient monitoring. Informed by the National Institute on Minority Health
and Health Disparities (NIMHD) Research Framework, this technology will be designed to address disparities
in AAD hospitalizations that disproportionately affect rural communities and minority patients. Once SafeBeat
Rx technology is validated on the target population (Phase II), future studies will compare hospital care with
home-based care guided by SafeBeat Rx. This proposal is supported by the manufacturer of the only FDA-
approved wearable cardioverter defibrillator (LifeVest, Zoll) and by insurers due to significant cost savings.
