Actively Recruiting
VenusP-Valve Pivotal Study (PROTEUS STUDY)
Led by Venus MedTech (HangZhou) Inc. · Updated on 2025-02-28
60
Participants Needed
1
Research Sites
533 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VenusP-Valve Pivotal Study (PROTEUS STUDY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Weight 25kg (55 lbs.)
- Age 25 12 years old
- Dysfunctional native RVOT with severe pulmonary regurgitation confirmed by echocardiography or cardiac MRI
- No significant pulmonary stenosis (gradient 25 25mmHg)
- Symptomatic patients with severe pulmonary regurgitation or asymptomatic patients meeting at least two criteria: mild/moderate RV or LV systolic dysfunction, severe RV dilation, or progressive reduction in exercise tolerance
- Willingness to consent and complete all follow-up requirements
You will not qualify if you...
- Signs of infection including active endocarditis
- Intracardiac mass, thrombus, or vegetation seen on echocardiography
- Significant blood disorders such as leukopenia, anemia, thrombocytopenia, or clotting disorders
- Unsuitable anatomy for femoral or right internal jugular vein access
- RVOT anatomy unfavorable for device anchoring or unable to accommodate delivery system
- Coronary artery compression risk from the valve replacement
- Emergency interventional or surgical procedures within 30 days before the implant
- Planned significant procedures at the time of implant or within 30 days after
- History of intravenous drug abuse without completed rehabilitation
- Life expectancy less than one year due to major non-cardiac disease
- Known allergies or contraindications to antiplatelet, antithrombotic medications, or materials in the device
- Positive pregnancy test in female patients of childbearing potential
- Participation in another investigational drug or device study
- Inability or unwillingness to provide informed consent or comply with follow-up
- Investigator judgment deeming the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Venusmedtech of America
Irvine, California, United States, 92618
Actively Recruiting
Research Team
C
Cong Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here