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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Transcatheter pulmonary valve implantation (TPVI)
DeviceA valve is implanted through a catheter (a narrow tube) and inserted through the femoral vein into the right atrium, right ventricle and pulmonary artery. After careful positioning, the valve is implanted by inflating a set of a balloons on the delivery catheter or self-expanding. After the catheter has been removed, the incision is closed with stitches, which are removed after the area has healed.
VenusP-ValveTM System
DeviceVenusP-ValveTM System consists of two components: 1. Transcatheter Pulmonary Valve (TPV) 2. Delivery System (DS) including Delivery Catheter System (DCS) and Compression Loading System (CLS) The TPV consists of a self-expanding nitinol stent with a single layer tri-leaflet porcine pericardium tissue. For the Delivery Catheter System (DCS) , the distal (deployment) end of the system features an atraumatic, radiopaque tip. A protective sheath (capsule) covers and maintains the TPV in a crimped position. The handle at the proximal end of the catheter is used to load and deploy the TPV. The CLS compresses the TPV into the catheter, which including capture tube, valve protection tube, tip support tube, loading mandrels and crimper.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: TPVIExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The rate of procedure or device related mortality at the 30 days follow-up visit post procedure
Freedom from procedure or device related mortality at 30 days
Time frame
At 30 Days Post Procedure2
The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit 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.
Time frame
At 6 Months Post ProcedureSecondary outcomes
1
The rate of all-cause mortality, procedure or device related mortality, and procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years
1. Freedom from all-cause mortality, procedure or device related mortality out to 10 years 2. Freedom from procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years 3. MACCE is defined as a non-hierarchic composite including the following procedure or device related events: 1\) Stroke 2) RVOT reintervention 3) Arrhythmia 4) Coronary artery compression requiring intervention or causing myocardial infarction 5) Device-related endocarditis 6) Major stent fracture 7) Valve thrombosis 8) Valve embolization or significant malposition 9) Major vascular or access complications\* 10) Pulmonary embolism
Time frame
Through Ten Years Post Procedure2
The rate of technical Success during the procedure
Technical success at exit from catheterization lab or operating room Defined as a composite of: 1. Freedom from procedure or device related mortality 2. Successful access, delivery of the device, and retrieval of the delivery system 3. Correct positioning of the valve(s) into the proper anatomical location 4. Freedom from reintervention related to the device or to a major vascular or access-related, or cardiac structural complications
Time frame
During the Procedure3
The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.
Acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years. Defined as: 1. Mean RVOT gradient ≤ 35mmHg AND, 2. No more than mild regurgitation measured by echocardiography
Time frame
At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure4
The rate of procedure success out to 30 days
Procedure success out to 30 days, defined as follows: 1. Device success at 30 days. Defined as a composite of: * Freedom from procedure or device related mortality * Original intended device in place * No additional surgical or interventional procedures related to the procedure or the device since completion of the index procedure * Hemodynamic performance: relief of insufficiency (mild or less pulmonary regurgitation) without producing the opposite (mean RVOT gradient \> 35 mmHg) as measured by echocardiography * No new ventricular arrhythmia requiring ICD implantation 2. None of the following procedure or device related serious adverse events: * Life-threatening major bleeding * Major vascular or cardiac structural complications requiring unplanned reintervention or surgery * Stage 2 or 3 acute kidney injury (AKI) includes new dialysis * Pulmonary embolism * Severe heart failure or hypotension requiring intravenous inotrope
Time frame
At 30 Days Post ProcedureSponsors and contacts
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Source ClinicalTrials.gov