Clinical Trial

VenusP-Valve Pivotal Study (PROTEUS STUDY)

Study acronym: PROTEUS
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 28, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-18; most recent amendment 2025-02-25.
Status change: Not Yet Recruiting → Recruiting 2024-06-17
Status change: Withheld → Not Yet Recruiting 2023-08-28
Trial Details
NCT Number NCT06010563
Lead Sponsor Venus MedTech (HangZhou) Inc.
Conditions Pulmonary Regurgitation
Enrollment 60 participants
Start Date 2024-06-11
Primary Completion 2026-06-30 (estimated)
Study Completion 2034-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-28