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

NCT06518681 | Enrolling By Invitation

• 1 other identifier: PoliaValve-SA-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Regurgitation

Keywords

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Regurgitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• EOA

  baseline and 1 month, 6months, 12months following patient enrollment completion

• Mean transvalvular pressure difference

  baseline and 1 month, 6months, 12months following patient enrollment completion

• Peak flow velocity

  baseline and 1 month, 6months, 12months following patient enrollment completion

• Regurgitation

  baseline and 1 month, 6months, 12months following patient enrollment completion

• New York Heart Association Assessment (NYHA)

  baseline and 1 month, 6months, 12months following patient enrollment completion

Study Arms (1)

PoliaValve (Aortic)

EXPERIMENTAL

Patients receiving the PoliaValve (Aortic) from HearrHill Medical

Device: PoliaValve (Aortic)

Interventions

PoliaValve (Aortic) DEVICE

Aortic Valve Replacement

PoliaValve (Aortic)

Eligibility Criteria

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

You may qualify if:

• Subjects must meet all the following conditions:
• Subjects are ≥60 years old;
• 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;
• The subject is diagnosed with severe aortic stenosis and/or regurgitation (or insufficiency) through echocardiography;
• 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.

You may not qualify if:

• Subjects must not meet any of the following conditions:
• 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;
• 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.;
• 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;
• Decompensated heart failure, cardiogenic shock, malignant arrhythmia, etc. that require mechanical circulatory assistance, mechanical ventilation or emergency surgery before surgery;
• Active endocarditis or vegetations on the heart within 3 months;
• History of severe acute myocardial infarction or cerebrovascular accident within 3 months (excluding lacunar infarction);
• Those with severe renal insufficiency (GFR \<30mL/min) or end-stage renal disease requiring long-term dialysis;
• Liver dysfunction or gastrointestinal dystrophy;
• Patients with active bleeding, bleeding tendency or unable to receive anticoagulation treatment;
• Those with severe ventilation or ventilatory dysfunction who require continuous oxygen therapy;
• 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;
• Other reasons causing life expectancy to be less than 1 year, such as malignant tumors and immunodeficiency diseases;
• Other situations in which patients are not suitable for artificial aortic valve replacement or are not suitable to participate in this trial.

Sponsors & Collaborators

• Suzhou Hearthill Medical Technology Co.,LTD: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: July 24, 2024
• Study Start: August 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)