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A Right Heart Catheter for Pressure-Volume Loop Risk Stratification for Percutaneous Valve Repair in Tricuspid Regurgitation

Award Number: R43HL182792
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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A Right Heart Catheter for Pressure-Volume Loop Risk Stratification for Percutaneous Valve Repair in Tricuspid Regurgitation - Abstract Tricuspid regurgitation (TR) is a common and serious finding in older patients (>70 years), with mortality 1 year after diagnosis with severe TR exceeding 20%. TR has traditionally been treated conservatively because it occurs commonly in older patients who have poor outcomes with open heart surgery. However, recent development of transcatheter interventions for tricuspid valve repair or replacement have led to an increase in the number of older patients eligible for surgical intervention. Despite 1.5 million patients being eligible for intervention in the US, determining who will benefit is still unclear. While many patients gain considerable quality of life benefit following intervention, others have catastrophic outcomes that include extended and grueling stays on extracorporeal membrane oxygenation in the intensive care unit. Right ventricular failure immediately following tricuspid procedures occurs at a much higher rate than similar procedures for other valves. This failure occurs when the patient’s right ventricle is too weak to withstand increases in load on the right heart that result from closure of the low resistance leaky tricuspid valve. Unfortunately, existing clinical measurements of right ventricular function at baseline by echocardiography or other imaging methods are heavily confounded by TR and can lead to function appearing “pseudo- normal”. Substantial clinical uncertainty therefore exists as to which patients will be able to withstand a tricuspid valve procedure. Improved patient selection requires more accurate measures of right ventricular function. Pressure-Volume (PV) loop analysis is the gold standard assessment of cardiac function and measures cardiac reserve in a load-independent manner that is not confounded by TR. Until now, this technique has been limited to research because it required an additional procedure over the clinical standard of care. BridgeSource Medical Corporation and clinical collaborators propose to solve these issues by incorporating Pressure-Volume measurements onto a standard right heart catheter to measure simultaneous right ventricular volumes in addition to pressures, enabling acquisition and analysis of PV loops. This development allows use of PV loop analysis in standard clinical practice, because right heart catheterization is part of the standard workup leading to a TR procedure and no second catheter or additional surgery is required. This new Right Heart Catheter will provide a more accurate risk stratification for patients with TR and prevent excessive morbidity and mortality particularly in older patients whose right ventricles cannot tolerate the procedure.


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: 2026 ( Subtotal = $320,727 )
2026	2026	BRIDGESOURCE MEDICAL, CORP.	3301 NORTHLAND DR STE 214	AUSTIN	TX	78731	TRAVIS	USA	Cardiovascular Diseases Research	000	1	8/24/2026	NEW	$320,727
														Subtotal = $320,727

Grand Total All Awards = $320,727

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A Right Heart Catheter for Pressure-Volume Loop Risk Stratification for Percutaneous Valve Repair in Tricuspid Regurgitation

Award Number: R43HL182792

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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