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VenusP-Valve for Pulmonary Regurgitation (PROTEUS STUDY)

This study is testing the VenusP-Valve™ System, a device used for Transcatheter Pulmonary Valve Implantation (TPVI), in people with severe pulmonary regurgitation (a condition where blood leaks backward through the pulmonary valve). The VenusP-Valve™ System is a new type of valve that is implanted using a catheter (a thin tube) inserted through a vein. The study aims to see how safe and effective this device is. You may be able to join if you are at least 12 years old, weigh at least 55 lbs (25 kg), and have severe pulmonary regurgitation. The study will measure success by looking at serious problems or death within 30 days, and whether the valve works well without needing another procedure after 6 months. The current recruitment status is unclear, but about 60 people are planned to be enrolled.

Study design
This is a multi-center study that will enroll about 60 participants. It is not randomized, meaning participants will not be assigned to different treatment groups by chance.
What's involved
After the procedure, you will have clinical visits at pre-discharge, 30 days, 6 months, 12 months, and then yearly for up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06010563

VenusP-Valve Pivotal Study (PROTEUS STUDY)

Recruiting
NAAges 12+InterventionalTreatment
Venus MedTech (HangZhou) Inc.
~60 participants
Updated 2025-02-28 on ClinicalTrials.gov
What's tested:Transcatheter pulmonary valve implantation (TPVI)VenusP-ValveTM System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The rate of procedure or device related mortality at the 30 days follow-up visit post procedure
Measured over At 30 Days Post Procedure
+1 more outcome measured

Conditions

Pulmonary Regurgitation

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Pulmonary Valvular Insufficiency

NCT06010563

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Venusmedtech of America

    Irvine, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Cong Ma
[email protected]
+8618817939751
Email the study team

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Eligibility criteria

Inclusion

Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the following criteria:
Mild or moderate RV or LV systolic dysfunction.
Severe RV dilation (RVEDVI ≥145 mL/m2 or RVESVI ≥ 75 mL/m2or RVEDV \>2 × LVEDV).
Progressive reduction in objective exercise tolerance. 4. Patient is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

What this trial measures

  • The rate of procedure or device related mortality at the 30 days follow-up visit post procedureAt 30 Days Post Procedure

    Freedom from procedure or device related mortality at 30 days

  • The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedureAt 6 Months Post Procedure

    Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as: 1. No more than mild regurgitation measured by CMR; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.