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Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction

Congenital Heart Disease Clinical Trial

Official title:
Prospective, Non-randomised, Open Label Clinical Study to Assess the Safety of the Bioabsorbable Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction

Clinical Trial Summary

The study is a prospective, non-randomised, open label clinical study to assess the safety of the Bioabsorbable Pulmonary Valved (PV) conduit (PV-001) in subjects > 2 years and < 22 years of age, undergoing Right Ventricular Outflow Tract (RVOT) reconstruction. It is a first in man feasibility study which will include 10-12 patients in up to 6 sites in Europe. The primary objective of the study is to assess the survival rate of subjects at 6 months following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001). Secondary objectives: 1. The survival rate of subjects at 12 months following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001) 2. The percentage of conduit failure at 6 months and 12 months, where conduit failure includes the need for reintervention or reoperation. 3. The pressure gradient across the pulmonary valve will have an acceptable level at 12 months follow up. 4. The pulmonary regurgitation measured will not exceed a moderate grading at 12 months follow up. 5. To evaluate the usability of the Bioabsorbable Pulmonary Valved Conduit (PV-001) during the surgical procedure, using exploratory parameters Long term safety will be assessed up to 60 months post implantation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02700100
Study type Interventional
Source Xeltis
Contact
Status Active, not recruiting
Phase N/A
Start date June 2016
Completion date April 2022
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