Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

A Transcatheter Pulmonary Valve System for the Growing Hearts of Young Children

Award Number: R01HL177288
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2030

Group Awards By:

View Award Description

A Transcatheter Pulmonary Valve System for the Growing Hearts of Young Children - PROJECT SUMMARY/ABSTRACT Congenital heart defects (CHDs) occur in ~1% of births in the U.S. and Europe. Owing to improved medical and surgical care, it is estimated that nowadays 83% of babies born with CHD in the U.S. survive infancy. It is currently estimated that at least 1 million children are living with a CHD in the U.S. Most of these patients are born with some degree of right ventricular outflow tract (RVOT) abnormalities that at some point require pulmonary valve replacement to mitigate the detrimental effects of pulmonary valve regurgitation (PVR) on the right ventricle (RV). To address PVR, transcatheter pulmonary valve replacement (TPVR) is currently performed for these patients. Current TPVR systems are limited by size constraints that preclude their use in very small patients. Though, evidence supports the benefits of earlier intervention—even through surgical approaches—before the onset of symptoms, as this strategy can help preserve RV function and improve long-term outcomes. However, neither current TPVR devices nor surgically implanted valves can accommodate somatic growth, necessitating repeat interventions as children mature. This limitation underscores the critical need for next-generation valve technologies capable of expanding with the patient and reducing the lifetime burden of reintervention. Supported by an R21 award, we have developed the IRIS Valve—a growth-accommodating, origami-inspired TPVR system deliverable through a 12-Fr sheath for children as small as 8 kg. Designed to expand from 12 to 20 mm via balloon dilation, the valve maintains full leaflet coaptation across sizes and is constructed from three thin porcine pericardial leaflets on a stainless-steel stent with an ePTFE skirt. We have successfully implanted the IRIS Valve in the pulmonary position of eight Yucatan piglets for long-term (6-month) studies, with fluoroscopic and echocardiographic assessments confirming proper placement and function without regurgitation. This study will assess the safety and feasibility of the IRIS Valve in 36 gender-balanced Yucatan piglets over 12 months. Because Yucatan piglets reach near-adult heart size within a year—mirroring the human transition from infancy to late adolescence—this model effectively captures the challenges of pediatric growth.18 We aim to investigate two main hypotheses: (1) tendencies toward structural valve deterioration (SVD) in IRIS Valve's thin porcine pericardial leaflets implanted at the pulmonary position, and (2) the IRIS Valve's effectiveness in maintaining a low-pressure gradient and preventing regurgitation over a 12-month period.


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 = $760,016 )
2026	2026	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Cardiovascular Diseases Research	000	1	7/23/2026	NEW	$760,016
														Subtotal = $760,016

Grand Total All Awards = $760,016

Top

All Categories

About

Search

Reports

Data Submission

Award Information

A Transcatheter Pulmonary Valve System for the Growing Hearts of Young Children

Award Number: R01HL177288

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2030

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer