Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p

Study Overview
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Brief Summary
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Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and native right ventricular outflow tract (RVOT) after surgical repair of RVOT.

Detailed Description
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Clinical experience to date with transcatheter pulmonary valve replacement has been limited to two balloon expandable systems, namely the Melody Valve (Medtronic Inc, Minneapolis, MN) and the Sapien valve (Edwards Lifesciences, Irvine, CA). Both valves have undergone clinical trials with good medium-term valve durability. Although both the Melody and the Sapien valves have been used in native outflow tracts with good success , limitations to the extended application of these valves have generally centered on the maximum diameter of the RVOT. Indeed in the majority of patients requiring pulmonary valve replacement (PVR), these balloon expandable systems are not large enough to maintain stable valve position within the dilated native RVOT.Therefore more recent efforts have concentrated on a self-expanding system to provide valve competence despite significant dilation of the native RVOT. Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the trial is to evaluate the safety and efficacy of the Venus-P Valve for PPVI in patients pulmonary regurgitation and native RVOT after surgical repair of RVOT.

Official Title
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Multi-center Trial of Percutaneous Pulmonary Valve Implantation Using Venus-P Valve for Patients With Severe Pulmonary Regurgitation and Native Right Ventricular Outflow Tract After Previous Surgical Repair

Conditions
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Pulmonary Regurgitation, Tetralogy of Fallot

Intervention / Treatment
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* Device: Venues-P Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract obstruction with trans-annulus or RVOT patch; right ventricular diastolic volume index: 130-160 mL/m2 measured by isotopic examination or cardiac MRI measurements; Age: ≥10 years and ≤60 years; Weight ≥18 Kg; Pulmonary annulus : 14- 31 mm; RVOT length ≥20mm ; Signing the informed consent; Any of the following conditions: ① symptomatic, ②progressive RV systolic dysfunction, ③ progressive tricuspid regurgitation (at least moderate), ④ RVOT obstruction with RV systolic pressure ≥80 mmHg, ⑤ Sustained atrial/ventricular arrhythmias. Exclusion Criteria: Pre-existing pulmonary artery stenosis or artificial pulmonary valve at any position; Severe chest wall deformity (funnel chest, etc.); Acute uncompensated heart failure; Active infection or endocarditis requiring antibiotic therapy; Leukopenia (white blood cell <3000 mm3); Acute or chronic anemia (hemoglobin <9 g/L); Platelet counts <10000 /mm3; Impossibly of delivering Venus-P to RVOT as judged by researcher s before procedure; Known allergy to aspirin or heparin; Positive urine or serum pregnancy test in female subjects.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRAS<br>pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract | Device: Venues-P Valve<br>* a Novel Self-Expanding Percutaneous Stent-Valve in the Native Right Ventricular Outflow Tract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right ventricular end diastolic volume index |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse cardiovascular events | death, severe arrhythmia, pericardial tamponade, emergency surgery, RVOT rupture, pulmonary artery perforation, cardiac shock, endocarditis, bleeding , and other complications caused by procedure | 48 hours | 
| Incidence of deaths or strokes | All cause deaths (cardiac death, and non cardiac death) or strokes | 12 months | 
| pulmonary pressure gradient | Max pressure gradient (PG) | 1,3,6,12 months | 
| grade of pulmonary regurgitation |  | 1,3,6,12 months | 
| New York Heart Association (NYHA) class |  | 1,3,6,12 months | 
| 6 minutes walk distance |  | 1,3,6,12 months |