The purpose of this study is to conduct the clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle,to collect evidence on the device's safety and performance. This prospective, multicenter, randomized controlled, non inferiority clinical trial is expected to enroll 198 subjects and conduct a 1:1 random grouping. The experimental group will use polymer material surgical aortic valves(PoliaVavle, HeartHill Medical, Suzhou China) for aortic valve replacement, while the control group will use bovine pericardial biological valves for aortic valve replacement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
198
The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement
The control group will undergo aortic valve replacement using bovine pericardial aortic valve
Survival rate without prosthetic valve events at 12 months post-surgery
Event-free survival of the prosthetic valve at 12 months postoperatively. The 12-month postoperative survival rate without artificial valve events. The event-free survival rate refers to patients who have not experienced any reasons for heart-related or non-heart-related deaths, moderate or severe artificial valve degeneration, or the need for re-intervention on the artificial valve within 12 months after surgery.
Time frame: 12 months following patient enrollment completion
Surgical success rate
Surgical success rate: Surgical success is defined as the prosthetic valve function within 1 month after surgery, the prosthetic valve has a transvalvular pressure difference of \<20mmHg or a peak flow rate of \< 3m/s, no moderate or above intravalvular regurgitation or paravalvular leakage), and the patient survives without re-intervention.
Time frame: 1 month following patient enrollment completion
Evaluation of postoperative artificial valve function(effective valve orifice area)
Use echocardiography to evaluate the effective valve orifice area to assess the hemodynamic Performance.
Time frame: baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(mean transvalvular pressure gradient)
Use echocardiography to evaluate the mean transvalvular pressure gradient.
Time frame: baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(peak flow velocity)
Use echocardiography to measure the peak flow velocity.
Time frame: baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(regurgitation)
Evaluate the presence or absence of intravalvular or paravalvular regurgitation during the follow-up period by echocardiography.
Time frame: baseline and 12months following patient enrollment completion
New York Heart Association Assessment (NYHA)
Evaluate the New York Heart Association (NYHA) assessment to determine the improvement in cardiac function.The NYHA classification of heart function consists of four levels, ranging from Class I to Class IV, with heart function progressively deteriorating.
Time frame: baseline and 12months following patient enrollment completion
Left ventricular ejection fraction(LVEF) change from baseline in postoperative echocardiographic
LVEF(%) change from baseline in postoperative echocardiography.
Time frame: baseline and 12 months post-surgery
Left ventricular end-systolic diameter(LVESD) change from baseline in postoperative echocardiographic
LVESD(mm) change from baseline in postoperative echocardiography.
Time frame: baseline and 12 months post-surgery
Left ventricular end-diastolic diameter(LVEDD) change from baseline in postoperative echocardiographic
LVEDD(mm) change from baseline in postoperative echocardiography.
Time frame: baseline and 12 months post-surgery
BNP or NT-proBNP
Measure BNP or NT-proBNP to get the changes in postoperative cardiac function from baseline.
Time frame: baseline and 12 months following patient enrollment completion
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