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Novel, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home

Award Number: R44HL167294
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/19/2024
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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Novel, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home - PROJECT ABSTRACT This proposal provides additional objectives to advance the research and entrepreneurial skills of the postdoctoral candidate and the parent award, which aims to improve cardiovascular outcomes and quality of life for atrial fibrillation (AF) patients by allowing them to safely start proven antiarrhythmic drugs (AADs). AF is the most common heart rhythm disorder (>38M cases worldwide) and causes significant morbidity and mortality. AADs reduce mortality unlike other AF drugs, but access is restricted by a three-day hospitalization required to start these oral drugs. 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 QTc changes predict adverse responses to AADs. For AF patients at low risk of proarrhythmia, the cost and risks of hospitalization may outweigh the benefits. SafeBeat developed the first machine learning algorithm to produce visually verifiable QTc measurements for any ECG format, enabling easy review or modification from a mobile phone. The high QTc accuracy (5±7 ms) enabled the algorithm to recommend AAD dosing with 95% accuracy compared to physicians. This proposal is supported by cardiac monitoring device manufacturers, hospital systems, and key opinion leaders in cardiology due to significant cost savings, improved long-term AF monitoring, and expanded AAD access. The goals of this proposal are facilitated by 1) assessment of patient and provider interaction for refinement of the SafeBeat platform, 2) evaluate patient and ECG characteristics as predictors of pharmacological cardioversion using AAD therapy to determine the best candidates for use of the platform, and 3) perform longitudinal follow up of study participants for usability and efficacy data.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $47,689 )
2025	2025	SAFEBEAT RX INC	20500 BELSHAW AVE DPTEXCA2206	CARSON	CA	90746	LOS ANGELES	USA	Cardiovascular Diseases Research	000	1	12/13/2024	SUPPLEMENT FOR EXPANSION	$47,689
														Subtotal = $47,689

Issue Date FY: 2024 ( Subtotal = $994,131 )
2024	2024	SAFEBEAT RX INC	4455 DUNCAN AVE STE 8N	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	000	1	7/19/2024	NEW	$994,131
														Subtotal = $994,131

Grand Total All Awards = $1,041,820

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Novel, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home

Award Number: R44HL167294

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/19/2024

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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