Trials / Not Yet Recruiting
Not Yet RecruitingNCT07531303
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 55 (estimated)
- Sponsor
- Venus MedTech (HangZhou) Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2029-12-01
- Completion
- 2030-06-01
- First posted
- 2026-04-15
- Last updated
- 2026-04-15
Source: ClinicalTrials.gov record NCT07531303. Inclusion in this directory is not an endorsement.