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

NCT07531303 | Not Yet Recruiting

• 1 other identifier: VTPP-24-05
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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..

Conditions

Native Right Ventricle Outflow Tract(RVOT) Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• 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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• The investigators consider that the patients are not suitable to participate in this study.

Sponsors & Collaborators

• Venus MedTech (HangZhou) Inc.: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: April 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04