Clinical Trial

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

Not Yet Recruiting
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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..
Trial Details
NCT Number NCT07531303
Lead Sponsor Venus MedTech (HangZhou) Inc.
Conditions Native Right Ventricle Outflow Tract(RVOT) Dysfunction
Enrollment 55 participants
Start Date 2026-05
Primary Completion 2029-12 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-15