VenusP-Valve Pivotal Study (PROTEUS STUDY)
ConditionPulmonary Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorVenus MedTech (HangZhou) Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Weight ≥25kg (55 lbs.)
Age ≥ 12 years olds
Mild or moderate RV or LV systolic dysfunction.
Severe RV dilation (RVEDVI ≥145 mL/m2 or RVESVI ≥ 75 mL/m2or RVEDV >2 × LVEDV).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Transcatheter pulmonary valve implantation (TPVI)
- VenusP-ValveTM System
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov