VenusP-Valve Pivotal Study (PROTEUS STUDY)

Recruiting now · Not applicable

Conditions studied: Pulmonary Regurgitation

In brief

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.

Key facts

Study ID

NCT06010563

Run by

Venus MedTech (HangZhou) Inc.

People needed

60

Starts

2024-06-11

Expected to finish

2034-08-30

Last updated by the study team

2025-02-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Weight ≥25kg (55 lbs.)
• Age ≥ 12 years olds
• Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography or pulmonary regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and without significant pulmonary stenosis (significant pulmonary stenosis is defined as gradient more than 25mmHg) and are clinically indicated for intervention:
• For symptomatic patients, fitting the following criteria:
• 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.

You may not qualify if…

• Clinical or biological signs of infection including active endocarditis.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists.
• Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System.
• RVOT anatomy or morphology that is unfavorable for device anchoring.
• Anatomy unable to accommodate VenusP-Valve delivery system.
• Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR).
• Emergency interventional/surgical procedures within 30 days prior to the index procedure.
• Planned significant and relevant concomitant procedure at time of VenusP-Valve implant.
• Any planned interventional/surgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant.
• Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist.
• Major or progressive non-cardiac disease resulting in a life expectancy of less than one year.
• Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement
• Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential.
• Currently participating in an investigational drug or another device study.
• Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements.
• The investigators consider that the patients are not suitable to participate in this research.

Where it is running

• Venusmedtech of America — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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