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

NCT ID: NCT06518681

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-12-30

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.

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PoliaValve (Aortic)

Patients receiving the PoliaValve (Aortic) from HearrHill Medical

Group Type: EXPERIMENTAL

PoliaValve (Aortic)

Intervention Type: DEVICE

Aortic Valve Replacement

Interventions

PoliaValve (Aortic)

Aortic Valve Replacement

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

PoliaValve-SA-01

Identifier Type: -

Identifier Source: org_study_id