Aortic Valve Disease, Aortic Valve Regurgitation, Aortic Valve Stenosis
Conditions
Brief summary
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.
Interventions
DEVICEArtificial polymer heart valves
The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement
DEVICEBovine pericardial aortic valve
The control group will undergo aortic valve replacement using bovine pericardial aortic valve
Sponsors
Suzhou Hearthill Medical Technology Co.,LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subjects are aged ≥18 years old; 2. The subjects understand the nature and purpose of the study, voluntarily participate, and sign the informed consent form. They agree to comply with the trial requirements, cooperate with surgical treatment and follow-up, and consent to relevant follow-up inquiries and examinations; 3. The subjects have been confirmed to have severe aortic valve stenosis and/or regurgitation (also known as insufficiency) through echocardiography; 4. According to the 2020 ACC/AHA guidelines for the management of patients with valvular heart disease, the subjects meet the indications for surgical aortic valve replacement and preoperative assessment recommends surgical aortic valve replacement.
Exclusion criteria
1. Other valve diseases with surgical indications, such as severe mitral regurgitation, severe tricuspid regurgitation, moderate or greater mitral stenosis, or a history of previous aortic or other valve replacement surgery; 2. Other severe cardiovascular conditions with surgical indications, such as Stanford A-type aortic dissection, aortic sinus aneurysm (sinus diameter \> 5.0cm), hypertrophic obstructive cardiomyopathy, diffuse three-vessel coronary artery disease, or placement of a left ventricular assist device in end-stage heart failure; 3. End-stage heart failure that is not reversible even with aortic valve surgery, such as severe left ventricular dysfunction (LVEF \< 25%), or severe heart failure that cannot be corrected, or severe pulmonary hypertension assessed by right heart catheterization, with planned postoperative Impella, IABP, or left ventricular assist; 4. Preoperative decompensated heart failure, cardiogenic shock, malignant arrhythmias, etc., requiring mechanical circulatory support, mechanical ventilation, or emergency surgery; 5. Active endocarditis within the past 3 months or the presence of cardiac vegetations; 6. Severe acute myocardial infarction or history of cerebrovascular accidents within the past 3 months (excluding lacunar infarcts); 7. Severe renal insufficiency (glomerular filtration rate \< 30mL/min) or end-stage renal disease requiring long-term dialysis; 8. Liver dysfunction or gastrointestinal malnutrition-related diseases; 9. Active bleeding, bleeding tendencies, or patients unable to receive anticoagulant therapy; 10. Severe respiratory or ventilatory dysfunction requiring continuous oxygen therapy; 11. Poor compliance or cognitive impairment (such as coma, Parkinson's disease, dementia, substance abuse), inability to follow study requirements or refusal to participate in follow-up visits; 12. Other conditions with an expected lifespan of less than 1 year, such as malignancies and immunodeficiency diseases; 13. Other situations not suitable for artificial aortic valve replacement or participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate without prosthetic valve events at 12 months post-surgery | 12 months following patient enrollment completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of postoperative artificial valve function(regurgitation) | baseline and 12months following patient enrollment completion | Evaluate the presence or absence of intravalvular or paravalvular regurgitation during the follow-up period by echocardiography. |
| Left ventricular end-systolic diameter(LVESD) change from baseline in postoperative echocardiographic | baseline and 12 months post-surgery | LVESD(mm) change from baseline in postoperative echocardiography. |
| Left ventricular end-diastolic diameter(LVEDD) change from baseline in postoperative echocardiographic | baseline and 12 months post-surgery | LVEDD(mm) change from baseline in postoperative echocardiography. |
| BNP or NT-proBNP | baseline and 12 months following patient enrollment completion | Measure BNP or NT-proBNP to get the changes in postoperative cardiac function from baseline. |
| Surgical success rate | 1 month following patient enrollment completion | 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. |
| Evaluation of postoperative artificial valve function(effective valve orifice area) | baseline and 12months following patient enrollment completion | Use echocardiography to evaluate the effective valve orifice area to assess the hemodynamic Performance. |
| Evaluation of postoperative artificial valve function(mean transvalvular pressure gradient) | baseline and 12months following patient enrollment completion | Use echocardiography to evaluate the mean transvalvular pressure gradient. |
| Evaluation of postoperative artificial valve function(peak flow velocity) | baseline and 12months following patient enrollment completion | Use echocardiography to measure the peak flow velocity. |
| New York Heart Association Assessment (NYHA) | baseline and 12months following patient enrollment completion | 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. |
| Left ventricular ejection fraction(LVEF) change from baseline in postoperative echocardiographic | baseline and 12 months post-surgery | LVEF(%) change from baseline in postoperative echocardiography. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of structural valve degeneration | 12months following patient enrollment completion | 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.). |
| The incidence of device-related adverse events | 12months following patient enrollment completion | 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. |
| Surgical adverse event rate | 12months following patient enrollment completion | 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. |
Contacts
Primary ContactFanglin Lu, MD
Backup ContactXiaoshen Yan
Outcome results
None listed