Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p (NCT02590679) | Clinical Trial Compass
UnknownPhase 2/3
Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p
China44 participantsStarted 2013-05
Plain-language summary
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.
Who can participate
Age range10 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: ①symptomatic, 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;