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.
The subjects are aged ≥18 years old;
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;
The subjects have been confirmed to have severe aortic valve stenosis and/or regurgitation (also known as insufficiency) through echocardiography;
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.
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;
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;
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;
Preoperative decompensated heart failure, cardiogenic shock, malignant arrhythmias, etc., requiring mechanical circulatory support, mechanical ventilation, or emergency surgery;
Parallel
Artificial polymer heart valves
DeviceThe experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement
Bovine pericardial aortic valve
DeviceThe 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.
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.
Evaluation of postoperative artificial valve function(effective valve orifice area)
Use echocardiography to evaluate the effective valve orifice area to assess the hemodynamic Performance.
Evaluation of postoperative artificial valve function(mean transvalvular pressure gradient)
Use echocardiography to evaluate the mean transvalvular pressure gradient.
Evaluation of postoperative artificial valve function(peak flow velocity)
Use echocardiography to measure the peak flow velocity.
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.
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.
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.).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
