Clinical trial NCT06518681: Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
Official title: Prospective Clinical Trial Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: Suzhou Hearthill Medical Technology Co.,LTD
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Compliance rate of prosthetic valve function
timeFrame: 1 month following patient enrollment completion
measure: Surgery success rate
timeFrame: 1 month following patient enrollment completion
Secondary outcomes:
measure: EOA
timeFrame: baseline and 1 month, 6months, 12months following patient enrollment completion
measure: Mean transvalvular pressure difference
timeFrame: baseline and 1 month, 6months, 12months following patient enrollment completion
measure: Peak flow velocity
timeFrame: baseline and 1 month, 6months, 12months following patient enrollment completion
measure: Regurgitation
timeFrame: baseline and 1 month, 6months, 12months following patient enrollment completion
measure: New York Heart Association Assessment (NYHA)
timeFrame: baseline and 1 month, 6months, 12months following patient enrollment completion
measure: BNP or NT-proBNP
timeFrame: baseline and 1 month, 12months following patient enrollment completion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References: