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

NCT06737757 | Not Yet Recruiting DMC

• 1 other identifier: PoliaValve-SA-02
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Other Outcomes (3)

• The incidence of device-related adverse events

  12months following patient enrollment completion

• Surgical adverse event rate

  12months following patient enrollment completion

• Incidence of structural valve degeneration

  12months following patient enrollment completion

Study Arms (2)

Experimental group(PoliaValve)

EXPERIMENTAL

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

Device: Artificial polymer heart valves

Control Group

ACTIVE COMPARATOR

Using bovine pericardium aortic valve for aortic valve replacement

Device: Bovine pericardial aortic valve

Interventions

Artificial polymer heart valves DEVICE

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

Experimental group(PoliaValve)

Bovine pericardial aortic valve DEVICE

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Other conditions with an expected lifespan of less than 1 year, such as malignancies and immunodeficiency diseases;
• Other situations not suitable for artificial aortic valve replacement or participation in this trial.

Sponsors & Collaborators

• Suzhou Hearthill Medical Technology Co.,LTD: lead

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• 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 CHAIR

Central Study Contacts

Fanglin Lu, MD

CONTACT

86-021-63240090; drlufanglin@yeah.net

Xiaoshen Yan

CONTACT

86-0512-87662295; kevin.yan@hearthillmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 17, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 30, 2024

Record last verified: 2024-12