Clinical trial NCT06737757: Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Disease
Aortic Valve Regurgitation
Lead sponsor: Suzhou Hearthill Medical Technology Co.,LTD
Sponsor class: INDUSTRY
First posted: 2024-12-17
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survival rate without prosthetic valve events at 12 months post-surgery
timeFrame: 12 months following patient enrollment completion
Secondary outcomes:
measure: Surgical success rate
timeFrame: 1 month following patient enrollment completion
measure: Evaluation of postoperative artificial valve function(effective valve orifice area)
timeFrame: baseline and 12months following patient enrollment completion
measure: Evaluation of postoperative artificial valve function(mean transvalvular pressure gradient)
timeFrame: baseline and 12months following patient enrollment completion
measure: Evaluation of postoperative artificial valve function(peak flow velocity)
timeFrame: baseline and 12months following patient enrollment completion
measure: Evaluation of postoperative artificial valve function(regurgitation)
timeFrame: baseline and 12months following patient enrollment completion
measure: New York Heart Association Assessment (NYHA)
timeFrame: baseline and 12months following patient enrollment completion
measure: Left ventricular ejection fraction(LVEF) change from baseline in postoperative echocardiographic
timeFrame: baseline and 12 months post-surgery
measure: Left ventricular end-systolic diameter(LVESD) change from baseline in postoperative echocardiographic
timeFrame: baseline and 12 months post-surgery
measure: Left ventricular end-diastolic diameter(LVEDD) change from baseline in postoperative echocardiographic
timeFrame: baseline and 12 months post-surgery
measure: BNP or NT-proBNP
timeFrame: baseline and 12 months following patient enrollment completion
Other outcomes:
measure: The incidence of device-related adverse events
timeFrame: 12months following patient enrollment completion
measure: Surgical adverse event rate
timeFrame: 12months following patient enrollment completion
measure: Incidence of structural valve degeneration
timeFrame: 12months following patient enrollment completion
Locations:
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Fanglin Lu, MD
role: STUDY_CHAIR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiangbin Pan, MD
role: STUDY_CHAIR
References: