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Minimally?Invasive?Cardiac?Sympathetic Denervation for Malignant Ventricular?Arrhythmia

Award Number: R44HL135957
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/04/2017
PERIOD OF PERFORMANCE END DATE: 02/28/2022

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Minimally?Invasive?Cardiac?Sympathetic Denervation for Malignant Ventricular?Arrhythmia - Sympathetic innervation of the heart plays a critical role in arrhythmogenesis and recent studies have highlighted the role of surgical sympathetic denervation in management of refractory ventricular arrhythmias. The procedure although safe is very invasive and performed via thoracoscopy using single lung ventilation. This is not tolerated by patients with lung disease or severe structural heart disease. Our proposal will validate a completely new minimally invasive method for cardiac sympathetic denervation that can be performed in the interventional labs to replace the current surgical denervation to treat arrhythmic disorders of the heart. Our approach is novel in that we are able to exploit the anatomy of the cardiac nerves to achieve bilateral sympathetic denervation at a single site in front of the tracheal bifurcation. We will also validate an acute assay for denervation that will guide the procedure and ensure success by acute confirmation and safety of the procedure by avoiding unnecessary ablation. This project will be completed in several sequential stages. In Phase I we will demonstrate the proof of concept by demonstrating anesthetic block of the cardiac sympathetic nerves in the pretracheal region and abolishing the cardiac sympathetic response to electrical stimulation of bilateral stellate ganglia. We will show the feasibility and efficacy of RF ablation in the pre-tracheal region in abolishing the stellate sympathetic response and demonstrate acute safety. In Phase II of this proposal we will design and build a stand-alone human grade trans-bronchial ablation device with ultrasound imaging capabilities that will enable easy and safe access to the pretracheal space to achieve ablation of the deep cardiac plexus. We will demonstrate safety and durability of transtracheal RF ablation in a porcine chronic survival model. Sympathetic over activity is uniformly associated with poor survival in all forms of heart disease. Successful completion of the specific aims will lead to development of a novel method and a device to interrupt cardiac sympathetic nerves. Abolishing cardiac response to abnormal neurally mediated sympathetic discharge may have an enormous role in treatment of other cardiac arrhythmias such as atrial fibrillation and cardiac disorders associated with abnormal sympathovagal balance such as heart failure.


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: 2022 ( Subtotal = $0 )
2022	2019	CORIDEA LLC	154 W 14TH ST	NEW YORK	NY	10011	NEW YORK	USA	Cardiovascular Diseases Research	000	3	7/14/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	3	7/5/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $742,382 )
2019	2019	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	001	3	2/25/2019	NON-COMPETING CONTINUATION	$742,382
2019	2017	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	1	1/31/2019	NEW	$0
														Subtotal = $742,382

Issue Date FY: 2018 ( Subtotal = $755,923 )
2018	2018	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	2	3/8/2018	EXTENSION WITH OR WITHOUT FUNDS	$755,923
														Subtotal = $755,923

Issue Date FY: 2017 ( Subtotal = $224,221 )
2017	2017	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	1	8/3/2017	NEW	$224,221
														Subtotal = $224,221

Grand Total All Awards = $1,722,526

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Minimally?Invasive?Cardiac?Sympathetic Denervation for Malignant Ventricular?Arrhythmia

Award Number: R44HL135957

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/04/2017

PERIOD OF PERFORMANCE END DATE: 02/28/2022

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