NCT02846753

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Venus MedTech (HangZhou) Inc. · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulmonary Regurgitation

Interventions

Type	Name	Description
PROCEDURE	trans catheter heart valve replacement	trans catheter heart valve replacement

Timeline

• Start date: 2016-08-17
• Primary completion: 2022-07-31
• Completion: 2024-12-31
• First posted: 2016-07-27
• Last updated: 2023-04-21