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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group(PoliaValve) | Experimental | Using artificial polymer heart valves(PoliaValve, Hearthill Medical) for aortic valve replacement |
|
| Control Group | Active Comparator | Using bovine pericardium aortic valve for aortic valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial polymer heart valves | Device | The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months following patient enrollment completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month following patient enrollment completion |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of device-related adverse events | The incidence of device-related adverse events: Valve-related complications include moderate or greater structural valve degeneration, valve thrombosis, valve-related thromboembolism, severe bleeding (due to anticoagulant use), severe paravalvular leak, and prosthetic valve endocarditis. | 12months following patient enrollment completion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanglin Lu, MD | Contact | 86-021-63240090 | drlufanglin@yeah.net | |
| Xiaoshen Yan | Contact | 86-0512-87662295 | kevin.yan@hearthillmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Fanglin Lu, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Xiangbin Pan, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
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| Bovine pericardial aortic valve | Device | The control group will undergo aortic valve replacement using bovine pericardial aortic valve |
|
| Evaluation of postoperative artificial valve function(effective valve orifice area) | Use echocardiography to evaluate the effective valve orifice area to assess the hemodynamic Performance. | 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. | baseline and 12months following patient enrollment completion |
| Evaluation of postoperative artificial valve function(peak flow velocity) | Use echocardiography to measure the peak flow velocity. | 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. | 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. | 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. | 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. | 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. | 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. | baseline and 12 months following patient enrollment completion |
| Surgical adverse event rate | Surgical adverse event rate: Surgical complications include severe lung infections, mediastinal or incision infections, postoperative severe hypotension, perioperative stroke, new-onset atrial fibrillation, new-onset complete atrioventricular block, acute kidney injury or worsening renal function requiring renal replacement therapy, severe bleeding, and cardiac tamponade. | 12months following patient enrollment completion |
| Incidence of structural valve degeneration | Incidence of structural valve degeneration: Structural valve degeneration refers to valve stenosis and/or regurgitation due to structural abnormalities of the valve itself (such as tearing, shedding, calcification, fibrosis, deformation of the valve frame, and rupture of the connecting parts between the valve components) as determined by reoperation or clinical examination (e.g., echocardiography, etc.). | 12months following patient enrollment completion |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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