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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGImprovement rate of RVEDV at 6 months post-procedure.
The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.
Time frame: At 6 months post-implantation of Venus-P valve
Safety Endpoints
Accumulated occurrences (rate of patients/year) of procedure-related clinical events (death, severe arrhythmias, cardiac tamponade, RVOT or pulmonary artery perforation or rupture, cardiac shock, endocarditis from the date of valve implantation up to 12 months post-procedure or bleeding due to use of heparin/aspirin at 48 hours post-procedure assessed per protocol. Occurrence of all deaths (cardiac death, non-cardiac deaths and other deaths) and stroke one year post-procedure.
Time frame: From the date of implantation until 12 months post-procedure
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