Clinical Research Directory

VenusP-Valve™ System Long-term Follow-up 6-10 Years

Sponsor: Venus MedTech (HangZhou) Inc.

Summary

The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753). Annual clinic visits will be conducted from year 6 through year 10 post-implantation, including transthoracic echocardiography, New York Heart Association (NYHA) functional classification assessment, adverse event evaluation, and review of cardiovascular medication use at each visit..

Official title: Long-term Follow-up Study of Implantation of the VenusP-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts

Key Details

Conditions