Right Ventricular Outflow Tract Stenosis Clinical Trial
Official title:
Efficacy and Safety Evaluation of Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract (RVOT) Stenosis After Congenital Heart Defect Surgical Correction Complicated With Severe Pulmonary Regurgitation
A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.
The aim of this protocol is to assess the efficacy, safety and performance of Venus P-valve.
Patients between 18-60 years with RVOT stenosis and moderate to severe pulmonary
regurgitation (≥3+) who have undergone trans-annular patch repair of their RVOT, cardiac
magnetic resonance (CMR) screening right ventricular end-diastolic volume index (RVEDVI)
between 130-160mL/m2.
Post-procedure follow-ups will be scheduled at 24 hours, 30 days, 6 months and 12 months.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment