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VenusP-Valve Pivotal Study (PROTEUS STUDY) — PROTEUS  

Pulmonary Regurgitation Clinical Trial

Official title:
Evaluation of the Performance Of The VenusP-ValveTM System in Patients With Native RVOT Dysfunction

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06010563
Study type Interventional
Source Venus MedTech (HangZhou) Inc.
Contact Cong Ma
Phone +8618817939751
Email macong@venusmedtech.com
Status Recruiting
Phase N/A
Start date June 11, 2024
Completion date August 30, 2034
View Details
See also
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Active, not recruiting NCT03130777 - ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent N/A
Active, not recruiting NCT02846753 - Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts N/A
Completed NCT00676689 - COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV N/A
Recruiting NCT04084132 - Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation N/A