clinical trial · NCT07531303
VenusP-Valve™ System Long-term Follow-up 6-10 Years
Venus MedTech (HangZhou) Inc.·—·not yet recruiting·n = 55
Native Right Ventricle Outflow Tract(RVOT) Dysfunction
brief 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..
started
May 1, 2026
primary completion
Dec 1, 2029
completion
Jun 1, 2030
last updated
Apr 15, 2026
official title
Long-term Follow-up Study of Implantation of the VenusP-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol