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

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..

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Key information

Conditions

Native Right Ventricle Outflow Tract(RVOT) Dysfunction

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.
- 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
- Moderate or greater pulmonary regurgitation by echocardiography at 6 years, 7 years, 8 years, 9 years and 10 years.

Sponsors and collaborators

Lead sponsor

Venus MedTech (HangZhou) Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Apr 15, 2026
Registry last updated: Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.