New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract

Summary

Valved conduits used for the reconstruction of right-ventricular outflow tract are applied in the surgical repair of complex congenital heart disease(CHD) such as pulmonary atresia(PA), truncus arteriosus, severe tetralogy of Fallot(TOF) for their significant roles in reducing pulmonary valve regurgitation and preserving right ventricle function. With a rising cases of complex CHD and patients with pulmonary valve regurgitation in TOF repair, a further demand is underway for valved conduits. Meanwhile, common biological valved conduits applied in foreign countries are not approved in China yet, with high failure and reintervention, reducing the long-term survival. Our team manufactured a novel valved conduit with 0.1mm expanded polytetrafluoroethylene and gore-tex conduit. This ePTFE valved conduit played a satisfying role in anti-regurgitation and failure rate through in vitro fluid test and animal experiments. Besides, our team manufactured templates for the conduit and also simplified the suturing process so that the repeatability of suturing valved had been risen. Until now, over 70 cases have been implanted with this ePTFE valved conduit with positive early and mid-term follow-up results.

Despite the progress which have been made, there still remain some problems to solve. First, systematic prospective randomized comparative study will be performed. Second, this is just a single-center study. Third, these patients should have longer follow-up time to evaluate the ePTFE conduit long-term effect. Finally, imaging data are blank for evaluating the function of the conduit and right ventricle. In this prospective comparative research, the new designed ePTFE valved conduit and bovine jugular vein valved conduits are conducted as a randomized controlled trail. Cardiac magnetic resonance imaging is used to precisely evaluate the anti-regurgitation effect of the valved conduit and the right ventricle function. Investigators can further access the application of this newly designed ePTFE valved conduit. Investigators aim to provide a self-manufactured, low failure rate valved conduit.

Conditions

• Right Ventricular Outflow Tract Absent
• Congenital Heart Disease
• Pulmonary Valve Disorders

Interventions

DEVICE

new-designed PTFE valved conduits

In this prospective comparative research, all patients will be divided into two groups randomly with 100 patients in each group. One group will use the new-designed PTFE valved conduits and another one will implant the bovine jugular vein valved conduits.

DEVICE

Bovine jugular vein valved conduits

In this prospective comparative research, all patients will be divided into two groups randomly with 100 patients in each group. One group will use the new-designed PTFE valved conduits and another one will implant the bovine jugular vein valved conduits.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Shanghai Children's Medical Center

  collaborator OTHER

• Children's Hospital of Fudan University

  lead OTHER

Principal Investigators

• Bing Jia, PhD · Children's Hospital of Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-01

Primary Completion

2021-12-31

Completion

2022-11-30

Countries

• China

Study Locations