Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Regurgitation
• Intervention / Treatment: Device: Artificial polymer heart valves; Device: Bovine pericardial aortic valve

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fanglin Lu, MD; Phone Number: 86-021-63240090; Email: drlufanglin@yeah.net
• Study Contact Backup: Name: Xiaoshen Yan; Phone Number: 86-0512-87662295; Email: kevin.yan@hearthillmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group(PoliaValve); Using artificial polymer heart valves(PoliaValve, Hearthill Medical) for aortic valve replacement	Device: Artificial polymer heart valves; The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement
Active Comparator: Control Group; Using bovine pericardium aortic valve for aortic valve replacement	Device: Bovine pericardial aortic valve; The control group will undergo aortic valve replacement using bovine pericardial aortic valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Suzhou Hearthill Medical Technology Co.,LTD
• Investigators: Study Chair: 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 record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Ventricular Outflow Obstruction; Congenital Abnormalities; Cardiovascular Abnormalities; Aortic Valve Disease; Aortic Valve Stenosis; Heart Defects, Congenital; Aortic Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: PoliaValve-SA-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No