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Leadless wirelessly powered pacemaker for multi chamber pacing using miniaturized pacing and sensing node

Award Number: R01HL144683
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 07/31/2024

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Leadless wirelessly powered pacemaker for multi chamber pacing using miniaturized pacing and sensing node - Project Summary Cardiovascular diseases claim more than 17 million lives worldwide every year. In the United States alone, 92.1 million people are affected by cardiovascular disease, and 32% of all major deaths are attributed to it. A portion of the cardiovascular disease population has abnormalities that necessitate implantation of a pacemaker to maintain normal heart rhythm. A pacemaker is a device that sends regular electrical impulses to the heart via long wires called leads connected to a generator placed underneath the skin. In the United States alone, pacemakers are implanted in more than 370,000 patients annually. Complications related to pacemaker implantation occur in 10% of these patients. These complications are largely device-related and include lead failure, lead dislodgement, infection, tricuspid regurgitation, and venous occlusion. Recent developments in pacemaker technology have led to leadless pacemakers, which have shrunk the pacemaker into a bullet-sized device that can be implanted inside the heart. However, these devices in their current form factor are too bulky to provide therapy to pediatric patients. To address this problem, we developed a miniature (11 mm × 11 mm), leadless, wirelessly powered pacing device that can pace multiple locations across the heart synchronously. Our successful experiments in pacing multiple chambers of the heart in vivo has led to the hypothesis that this approach of multisite pacing will our technology will enable the development of miniature devices that will provide leadless, wirelessly powered means of pacing at unprecedented numbers of sites and in previously inaccessible regions, thereby enhancing myocardial synchronization and conduction. In this proposal, we aim to develop a system comprising of a distributed network of wirelessly powered pacing and sensing nodes (SA 1) that can be controlled by a data-driven algorithm (SA 2) to provide optimal cardiac resynchronization therapy. This system will be iteratively developed and validated in a subacute in vivo porcine model of heart failure (SA 3). Drs. Babakhani, Cavallaro, and Lin will each contribute to the hardware development. Dr. Aazhang will supervise the development of the data-driven algorithm, and Dr. Razavi will oversee device development and all animal studies. Research outcomes from this project will improve our understanding of wireless power transfer, lead to the creation of novel intracorporeal inter-device communication protocols, and offer an innovative approach to pacing therapies. The device in its refined state will be small enough for transvenous delivery, capable of synchronous pacing and sensing from multiple locations, and deliver appropriate personalized therapy by using algorithms to detect patient-specific rhythm abnormalities. Such a device will have far-reaching clinical impact by allowing pacing at multiple locations, including those that were previously inaccessible. Furthermore, the device will normalize conduction across a damaged heart to better manage arrhythmia and can provide imperceptible low-energy defibrillation for painless cardioversion.


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 = -$22 )
2025	2022	TEXAS HEART INSTITUTE	6770 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Cardiovascular Diseases Research	000	4	12/16/2024	NON-COMPETING CONTINUATION	-$22
														Subtotal = -$22

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	TEXAS HEART INSTITUTE	6770 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Cardiovascular Diseases Research	000	4	11/13/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	TEXAS HEART INSTITUTE	6770 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Cardiovascular Diseases Research	001	4	9/2/2023	NON-COMPETING CONTINUATION	$0
2023	2022	TEXAS HEART INSTITUTE	6770 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Cardiovascular Diseases Research	000	4	11/2/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $607,994 )
2022	2022	TEXAS HEART INSTITUTE	6770 BERTNER AVE MC3 117	HOUSTON	TX	77030	HARRIS	USA	Cardiovascular Diseases Research	000	4	8/19/2022	NON-COMPETING CONTINUATION	$607,994
														Subtotal = $607,994

Issue Date FY: 2021 ( Subtotal = $593,955 )
2021	2021	TEXAS HEART INSTITUTE	6770 BERTNER AVE MC3 117	HOUSTON	TX	77030	HARRIS	USA	Cardiovascular Diseases Research	000	3	8/9/2021	NON-COMPETING CONTINUATION	$593,955
														Subtotal = $593,955

Issue Date FY: 2020 ( Subtotal = $575,514 )
2020	2020	TEXAS HEART INSTITUTE	6770 BERTNER AVE MC3 117	HOUSTON	TX	77030	HARRIS	USA	Cardiovascular Diseases Research	000	2	8/14/2020	NON-COMPETING CONTINUATION	$575,514
														Subtotal = $575,514

Issue Date FY: 2019 ( Subtotal = $615,993 )
2019	2019	TEXAS HEART INSTITUTE	6770 BERTNER AVE MC3 117	HOUSTON	TX	77030	HARRIS	USA	Cardiovascular Diseases Research	000	1	8/28/2019	NEW	$615,993
														Subtotal = $615,993

Grand Total All Awards = $2,393,434

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Leadless wirelessly powered pacemaker for multi chamber pacing using miniaturized pacing and sensing node

Award Number: R01HL144683

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 07/31/2024

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