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

NCT ID: NCT06737757

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2029-12-31

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group(PoliaValve)

Using artificial polymer heart valves(PoliaValve, Hearthill Medical) for aortic valve replacement

Group Type: EXPERIMENTAL

Artificial polymer heart valves

Intervention Type: DEVICE

The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement

Control Group

Using bovine pericardium aortic valve for aortic valve replacement

Group Type: ACTIVE_COMPARATOR

Bovine pericardial aortic valve

Intervention Type: DEVICE

The control group will undergo aortic valve replacement using bovine pericardial aortic valve

Interventions

Artificial polymer heart valves

The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement

Intervention Type: DEVICE

Bovine pericardial aortic valve

The control group will undergo aortic valve replacement using bovine pericardial aortic valve

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Hearthill Medical Technology Co.,LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fanglin Lu, MD

Role: STUDY_CHAIR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Xiangbin Pan, MD

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences, Fuwai Hospital

Central Contacts

Fanglin Lu, MD

Role: CONTACT

Phone: 86-021-63240090

Email: drlufanglin@yeah.net

Xiaoshen Yan

Role: CONTACT

Phone: 86-0512-87662295

Email: kevin.yan@hearthillmedical.com

Other Identifiers

PoliaValve-SA-02

Identifier Type: -

Identifier Source: org_study_id