Trials / Recruiting
RecruitingNCT05835349
Observational Study of Venus P-Valve
A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Venus MedTech (HangZhou) Inc. · Industry
- Sex
- All
- Age
- 12 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).
Detailed description
All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required. Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | transcatheter pulmonary valve implantation (TPVI) | A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve. |
Timeline
- Start date
- 2024-08-26
- Primary completion
- 2026-08-01
- Completion
- 2032-12-01
- First posted
- 2023-04-28
- Last updated
- 2025-01-24
Locations
10 sites across 4 countries: France, Germany, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT05835349. Inclusion in this directory is not an endorsement.