Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease

Suzhou Hearthill Medical Technology Co.,LTD0 sites198 target enrollmentDecember 2024

ConditionsAortic Valve Stenosis Aortic Valve Disease Aortic Valve Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Suzhou Hearthill Medical Technology Co.,LTD
Enrollment: 198
Primary Endpoint: Survival rate without prosthetic valve events at 12 months post-surgery
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2024

End Date

December 2029

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Hearthill Medical Technology Co.,LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;
•Active endocarditis within the past 3 months or the presence of cardiac vegetations;
•Severe acute myocardial infarction or history of cerebrovascular accidents within the past 3 months (excluding lacunar infarcts);
•Severe renal insufficiency (glomerular filtration rate \< 30mL/min) or end-stage renal disease requiring long-term dialysis;
•Liver dysfunction or gastrointestinal malnutrition-related diseases;
•Active bleeding, bleeding tendencies, or patients unable to receive anticoagulant therapy;
•Severe respiratory or ventilatory dysfunction requiring continuous oxygen therapy;

Outcomes

Primary Outcomes

Survival rate without prosthetic valve events at 12 months post-surgery

Time Frame: 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 Outcomes

Surgical success rate(1 month following patient enrollment completion)
Evaluation of postoperative artificial valve function(effective valve orifice area)(baseline and 12months following patient enrollment completion)
Evaluation of postoperative artificial valve function(mean transvalvular pressure gradient)(baseline and 12months following patient enrollment completion)
Evaluation of postoperative artificial valve function(peak flow velocity)(baseline and 12months following patient enrollment completion)
Evaluation of postoperative artificial valve function(regurgitation)(baseline and 12months following patient enrollment completion)
New York Heart Association Assessment (NYHA)(baseline and 12months following patient enrollment completion)
Left ventricular ejection fraction(LVEF) change from baseline in postoperative echocardiographic(baseline and 12 months post-surgery)
Left ventricular end-systolic diameter(LVESD) change from baseline in postoperative echocardiographic(baseline and 12 months post-surgery)
Left ventricular end-diastolic diameter(LVEDD) change from baseline in postoperative echocardiographic(baseline and 12 months post-surgery)
BNP or NT-proBNP(baseline and 12 months following patient enrollment completion)