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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07531303

Enrollment

Registered

2026-04-15

Start date

2026-05-01

Completion date

2030-06-01

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Native Right Ventricle Outflow Tract(RVOT) Dysfunction

Brief 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..

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Measure	Time frame	Description
adverse events and moderate or greater pulmonary regurgitation at 6 years, 7 years, 8 years, 9 years and 10 years.	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.

Outcome results