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

April 8, 2026 updated by: Venus MedTech (HangZhou) Inc.

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

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..

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

55

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right ventricular reverse remodeling and improvement rate of right ventricular function were followed up at 6 months after operation
Time Frame: From enrollment to month-6 post procedure.
The right ventricular reverse remodeling and the improvement rate of right ventricular function at 6 months after operation were defined as the 6-month follow-up The right ventricular end-diastolic volume index measured by CMR was within the normal range, that is, RVEDVI≤108mL/m2.
From enrollment to month-6 post procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events and moderate or greater pulmonary regurgitation at 6 years, 7 years, 8 years, 9 years and 10 years.
Time Frame: From enrollment to 10 years post procedure.

  1. Occurrence of the following adverse events at 6 years, 7 years, 8 years, 9 years and 10 years:

    • Device migration/embolization
    • Valvar thrombosis
    • Thromboembolism
    • Bleeding
    • Paravalvular leak
    • Endocarditis
    • Nonstructural dysfunction
    • Explant
    • Hemolysis
    • Arrhythmias
  2. Moderate or greater pulmonary regurgitation by echocardiography at 6 years, 7 years, 8 years, 9 years and 10 years.
From enrollment to 10 years post procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Venus MedTech (HangZhou) Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • VTPP-24-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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