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

NCT07531303 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2026-04-15

No results posted yet for this study

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..

Conditions

  • Native Right Ventricle Outflow Tract(RVOT) Dysfunction

Sponsors & Collaborators

  • Venus MedTech (HangZhou) Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-12-31
Completion
2030-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531303 on ClinicalTrials.gov