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Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts

Pulmonary Regurgitation Clinical Trial

Official title:
Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts

Clinical Trial Summary

A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.

Clinical Trial Description

This study evaluates the implantation of the Venus P-Valve™ for the treatment of patients with an incompetent pulmonic valve, which causes blood to flow back from the pulmonary artery into the right heart ventricle during pumping of the heart (pulmonary regurgitation). Patients with and without narrowing (stenosis) of the right ventricular outflow tract will be included. The purpose of this protocol is to assess the safety and performance of Venus P-Valve™ implantation. Post-procedure, a clinical visit will be scheduled at 30 days, 6 month, 12 months, and annually thereafter to 3 years. Population: Patients≥12 years with a body weight of ≥30kg, with significant pulmonary regurgitation (≥3+) with or without right ventricular outflow tract (RVOT) stenosis (mean Doppler gradient ≥35mmHg) with native right ventricular outflow tracts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02846753
Study type Interventional
Source Venus MedTech (HangZhou) Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date August 17, 2016
Completion date December 31, 2024
View Details
See also
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Active, not recruiting NCT03471936 - Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease N/A
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Active, not recruiting NCT03130777 - ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent N/A
Completed NCT00676689 - COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV N/A
Recruiting NCT04084132 - Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation N/A