Clinical Trial

Observational Study of Venus P-Valve

Study acronym: Registry
Recruiting
View on ClinicalTrials.gov →
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).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-04-18; most recent amendment 2025-01-21.
Status change: Not Yet Recruiting → Recruiting 2025-01-07
Trial Details
NCT Number NCT05835349
Lead Sponsor Venus MedTech (HangZhou) Inc.
Collaborators: IQVIA MedTech BV of Antwerp, Belgium, MDCECRO LLC
Conditions Right Ventricular Outflow Tract Dysfunction
Enrollment 200 participants
Start Date 2024-08-26
Primary Completion 2026-08 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-24