Status:
RECRUITING
VenusP-Valve Pivotal Study (PROTEUS STUDY)
Lead Sponsor:
Venus MedTech (HangZhou) Inc.
Conditions:
Pulmonary Regurgitation
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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) dy...
Eligibility Criteria
Inclusion
- 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:
- 1\) 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2034
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06010563
Start Date
June 11 2024
End Date
August 30 2034
Last Update
February 28 2025
Active Locations (1)
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1
Venusmedtech of America
Irvine, California, United States, 92618