Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease

Prospective Clinical Trial Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease

The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Regurgitation
• Intervention / Treatment: Device: PoliaValve (Aortic)

Detailed Description

The polymer aortic valve, PoliaValve, from HeartHIll Medical, is indicated as a replacement for patients with severe aortic valve disease, including severe aortic stenosis, severe aortic regurgitation, or both. These patients will be included in the study after systematic assessment that the subjects meet the criteria for inclusion in the study.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Subjects must meet all the following conditions:

1. Subjects are ≥60 years old;
2. The subjects understand the nature and purpose of the research, voluntarily participate and sign the informed consent form, comply with the trial requirements, are willing to cooperate with surgical treatment and follow-up, and agree to relevant follow-up interviews and examinations;
3. The subject is diagnosed with severe aortic stenosis and/or regurgitation (or insufficiency) through echocardiography;
4. According to the 2020 ACC/AHA management guidelines for patients with valvular heart disease, the subject meets the indications for aortic valve replacement surgery and the preoperative assessment recommends surgical aortic valve replacement.

Exclusion Criteria:

Subjects must not meet any of the following conditions:

1. Other valve diseases with indications for surgery, such as severe mitral regurgitation, severe tricuspid regurgitation, moderate or above mitral stenosis, etc. require combined valve replacement, or had aortic valve surgery in the past;
2. Other serious cardiovascular diseases with indications for surgery, such as Stanford type A aortic dissection, aortic sinus aneurysm (sinus diameter >5.0cm), hypertrophic obstructive cardiomyopathy, diffuse three-vessel coronary artery disease , end-stage heart failure while simultaneously placing a left ventricular assist device, etc.;
3. End-stage heart failure that is expected to be irreversible by aortic valve surgery, such as severe left ventricular dysfunction with LVEF <25%, or severe heart failure that cannot be corrected, or severe pulmonary hypertension assessed by right heart catheterization, predict postoperative plans Perform Impella, IABP or left ventricular assist within the hospital;
4. Decompensated heart failure, cardiogenic shock, malignant arrhythmia, etc. that require mechanical circulatory assistance, mechanical ventilation or emergency surgery before surgery;
5. Active endocarditis or vegetations on the heart within 3 months;
6. History of severe acute myocardial infarction or cerebrovascular accident within 3 months (excluding lacunar infarction);
7. Those with severe renal insufficiency (GFR <30mL/min) or end-stage renal disease requiring long-term dialysis;
8. Liver dysfunction or gastrointestinal dystrophy;
9. Patients with active bleeding, bleeding tendency or unable to receive anticoagulation treatment;
10. Those with severe ventilation or ventilatory dysfunction who require continuous oxygen therapy;
11. Those who have poor compliance or cognitive impairment (such as coma, Parkinson's disease, Alzheimer's disease, drug abuse), are unable to comply with requirements or refuse to cooperate in completing study follow-up visits;
12. Other reasons causing life expectancy to be less than 1 year, such as malignant tumors and immunodeficiency diseases;
13. Other situations in which patients are not suitable for artificial aortic valve replacement or are not suitable to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PoliaValve (Aortic); Patients receiving the PoliaValve (Aortic) from HearrHill Medical	Device: PoliaValve (Aortic); Aortic Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance rate of prosthetic valve function	The compliance rate of prosthetic valve function evaluation at 1 month after surgery. The standard of prosthetic valve function is as follows: prosthetic valve pressure difference <20mmHg or peak flow rate < 3m/s, no moderate or above intravalvular regurgitation or paravalvular leakage), and no reintervention is required.	1 month following patient enrollment completion
Surgery success rate	Event-free survival of the prosthetic valve at 1 month postoperatively. Prosthetic valve degeneration includes stenosis and/or regurgitation due to structural abnormalities of the valve itself (e.g., leaflet tears, detachment, calcification, fibrosis, deformation of the valve frame, and fracture of the material of the connecting parts between the valve components) (referred to as structural valve degeneration), as well as dysfunction due to infective endocarditis, perivalvular leakage, valve prosthesis-patient mismatch, valve displacement, and leaflet thrombosis (referred to as nonstructural valve degeneration). Prosthetic valve degeneration usually consists of three stages, with the first stage consisting of morphological evidence of valve degeneration and structural abnormalities, before significant hemodynamic changes are evident.	1 month following patient enrollment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EOA	Use echocardiography to evaluate the effective valve orifice area(EOA) to assess the hemodynamic Performance.	baseline and 1 month, 6months, 12months following patient enrollment completion
Mean transvalvular pressure difference	Use echocardiography to measure the mean transvalvular pressure difference.	baseline and 1 month, 6months, 12months following patient enrollment completion
Peak flow velocity	Use echocardiography to measure the peak flow velocity.	baseline and 1 month, 6months, 12months following patient enrollment completion
Regurgitation	Evaluate the presence or absence of intravalvular or paravalvular regurgitation during the follow-up period by echocardiography.	baseline and 1 month, 6months, 12months following patient enrollment completion
New York Heart Association Assessment (NYHA)	Evaluate New York Heart Association Assessment (NYHA) to see Heart Function Improvement.	baseline and 1 month, 6months, 12months following patient enrollment completion
BNP or NT-proBNP	Measure BNP or NT-proBNP to get the changes in postoperative cardiac function from baseline.	baseline and 1 month, 12months following patient enrollment completion

Collaborators and Investigators

• Sponsor: Suzhou Hearthill Medical Technology Co.,LTD

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Aortic Valve Stenosis; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Aortic Valve Regurgitation
• 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-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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