# An expandable polymeric valved conduit to repair congenital heart disease

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2022 · $562,061

## Abstract

Project Summary: More than 16,000 US children need the implantation of a valved conduit to replace the right
ventricular outflow tract (RVOT) annually. These children require one to four repeat open-heart surgeries to
replace the valved conduit before they reach adulthood because available prostheses do not grow with the child.
The long-term goal of our multidisciplinary collaborative team is to develop a biostable polymeric valved conduit
that can be implanted surgically to reconstruct the RVOT and then expanded (by successive transcatheter
procedures) to avoid multiple surgeries in children. Our overall objective is to design, validate and demonstrate
the in vitro and in vivo proof of concept of the expandability and valvar competence of the device. Our central
hypothesis is that the use and controlled processing of a biostable polymer with adequate plasticity, associated
to an optimized design of the valve, can allow for successive controlled expansions while maintaining valve
competence. We will test this hypothesis in the following three specific aims: Aim1: Characterize the growth
accommodation of non-valved conduits. We will 1.1) characterize the mechanical properties of 8 ePTFE
materials with varying densities and thicknesses using a uniaxial tensile tester, 1.2) develop a computational
model of tube expansion from 12-24 mm based on the mechanical data, and 1.3) validate the expansion
experimentally using a transcatheter balloon and measuring the expansion potential, uniaxial tensile properties
and microarchitecture. Aim 2: Develop a valve design for competence at all diameters. Our hypothesis is that a
valve design with increased height of coaptation and increased length of the free edge can be expanded from a
12-24 mm diameter while maintaining valve competence. We will use a fluid-structure interaction based
computational design, prototype fabrication, and experimental validation in our heart valve pulse duplicator to
iteratively examine the effects of the design on the hemodynamic performance of the valved conduit. Aim 3:
Describe the performance and durability of the valved conduit. We will 3.1) characterize the biocompatibility
using an aortic rat model; 3.2) demonstrate the acute in vivo performance in a sheep model; 3.3) assess the in
vitro durability in an accelerated wear tester. Expected outcomes: to have identified the conditions of the
fabrication process, optimized the valve hydrodynamics for different stages of expansion and performed the in
vitro and in vivo proof of concept of the biocompatibility, expandability and maintenance of the valvar competence
of the device. The innovation of the proposed research is that we will develop a valved conduit designed
specifically for growth-accommodation that is durable and competent at every stage of expansion, using and
developing innovative designs, computational models, manufacturing techniques and translational
methodologies. Impact and significance: our results will contribute ...

## Key facts

- **NIH application ID:** 10318136
- **Project number:** 5R01HL155381-02
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** David Kalfa
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $562,061
- **Award type:** 5
- **Project period:** 2020-12-15 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10318136

## Citation

> US National Institutes of Health, RePORTER application 10318136, An expandable polymeric valved conduit to repair congenital heart disease (5R01HL155381-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10318136. Licensed CC0.

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