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Painless Defibrillation

Award Number: R44HL127771
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2015
PERIOD OF PERFORMANCE END DATE: 04/30/2022

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Painless Defibrillation - Project Summary The purpose of the proposed work is first-in-man testing of novel painless defibrillation (PaDe) therapy. Sudden cardiac arrest (SCA) remains the number one killer in western civilization. The underlying mechanism of SCA is usually ventricular fibrillation (VF), and survival depends on prompt defibrillation. Existing defibrillators rely on the delivery of a brief high voltage shock to the heart. While this is life-saving, the shock is extremely painful when delivered to a conscious patient, as typically happens when the therapy is provided by an ICD. The pain caused by standard ICD shocks is due to the abrupt contraction of skeletal muscles of the chest and abdomen when the shock is applied to the heart. Our team has developed a novel means to accomplish painless defibrillation using a burst of high frequency alternating current to tetanize skeletal muscle so it does not further contract when a defibrillatory shock is then applied. We have already proven substantial reduction in skeletal muscle activation in animals defibrillated using this technology, and therefore believe that delivery of this novel therapy in humans will be a far less painful alternative to standard defibrillation shocks. In the proposed work, a table-top PaDe system developed in our Phase II grant will undergo final verification and validation testing needed to obtain FDA approval of an IDE, which will then enable us to evaluate this therapy in patients coming for elective ICD replacement. Patients will receive one PaDe therapy and one standard shock in random order, and will report the pain perceived with each of these, blinded to which is which. We intend to show that PaDe therapy is safe and effective, and will then seek FDA approval of the therapy.


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: 2023 ( Subtotal = $0 )
2023	2020	CORIDEA LLC	154 W 14TH ST	NEW YORK	NY	10011	NEW YORK	USA	Cardiovascular Diseases Research	000	5	11/15/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $982,600 )
2020	2020	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	5	5/2/2020	NON-COMPETING CONTINUATION	$982,600
														Subtotal = $982,600

Issue Date FY: 2019 ( Subtotal = $993,536 )
2019	2019	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	001	4	4/24/2019	NON-COMPETING CONTINUATION	$993,536
2019	2018	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	3	12/13/2018	COMPETING CONTINUATION	$0
														Subtotal = $993,536

Issue Date FY: 2018 ( Subtotal = $994,306 )
2018	2018	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	3	5/10/2018	COMPETING CONTINUATION	$994,306
														Subtotal = $994,306

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	CORIDEA, LLC	336 W 37TH ST RM 720	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	2	8/1/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $492,501 )
2016	2016	CORIDEA, LLC	336 W 37TH ST	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	2	3/31/2016	NON-COMPETING CONTINUATION	$492,501
														Subtotal = $492,501

Issue Date FY: 2015 ( Subtotal = $505,020 )
2015	2015	CORIDEA, LLC	336 W 37TH ST	NEW YORK	NY	10018	NEW YORK	USA	Cardiovascular Diseases Research	000	1	3/6/2015	NEW	$505,020
														Subtotal = $505,020

Grand Total All Awards = $3,967,963

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Painless Defibrillation

Award Number: R44HL127771

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2015

PERIOD OF PERFORMANCE END DATE: 04/30/2022

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