Not Yet RecruitingNot Applicable

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

55 participantsStarted 2026-05

Plain-language 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..

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the ethics committee and regulatory authority if applicable of the respective clinical site Exclusion Criteria: * The investigators consider that the patients are not suitable to participate in this study.

What they're measuring

Right ventricular reverse remodeling and improvement rate of right ventricular function were followed up at 6 months after operation

Timeframe: From enrollment to month-6 post procedure.

Trial details

NCT IDNCT07531303

SponsorVenus MedTech (HangZhou) Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-12

View on ClinicalTrials.gov More Native Right Ventricle Outflow Tract(RVOT) Dysfunction trials