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

December 23, 2024 updated by: Suzhou Hearthill Medical Technology Co.,LTD

Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subjects are aged ≥18 years old;
  2. 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;
  3. The subjects have been confirmed to have severe aortic valve stenosis and/or regurgitation (also known as insufficiency) through echocardiography;
  4. 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.

Exclusion Criteria:

  1. 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;
  2. 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;
  3. 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;
  4. Preoperative decompensated heart failure, cardiogenic shock, malignant arrhythmias, etc., requiring mechanical circulatory support, mechanical ventilation, or emergency surgery;
  5. Active endocarditis within the past 3 months or the presence of cardiac vegetations;
  6. Severe acute myocardial infarction or history of cerebrovascular accidents within the past 3 months (excluding lacunar infarcts);
  7. Severe renal insufficiency (glomerular filtration rate < 30mL/min) or end-stage renal disease requiring long-term dialysis;
  8. Liver dysfunction or gastrointestinal malnutrition-related diseases;
  9. Active bleeding, bleeding tendencies, or patients unable to receive anticoagulant therapy;
  10. Severe respiratory or ventilatory dysfunction requiring continuous oxygen therapy;
  11. 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;
  12. Other conditions with an expected lifespan of less than 1 year, such as malignancies and immunodeficiency diseases;
  13. Other situations not suitable for artificial aortic valve replacement or participation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group(PoliaValve)
Using artificial polymer heart valves(PoliaValve, Hearthill Medical) for aortic valve replacement
Device: Artificial polymer heart valves
The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement
Active Comparator: Control Group
Using bovine pericardium aortic valve for aortic valve replacement
Device: Bovine pericardial aortic valve
The control group will undergo aortic valve replacement using bovine pericardial aortic valve

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival rate without prosthetic valve events at 12 months post-surgery
Time Frame: 12 months following patient enrollment completion
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surgical success rate
Time Frame: 1 month following patient enrollment completion
Surgical success rate: Surgical success is defined as the prosthetic valve function within 1 month after surgery, the prosthetic valve has a transvalvular pressure difference of <20mmHg or a peak flow rate of < 3m/s, no moderate or above intravalvular regurgitation or paravalvular leakage), and the patient survives without re-intervention.
1 month following patient enrollment completion
Evaluation of postoperative artificial valve function(effective valve orifice area)
Time Frame: baseline and 12months following patient enrollment completion
Use echocardiography to evaluate the effective valve orifice area to assess the hemodynamic Performance.
baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(mean transvalvular pressure gradient)
Time Frame: baseline and 12months following patient enrollment completion
Use echocardiography to evaluate the mean transvalvular pressure gradient.
baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(peak flow velocity)
Time Frame: baseline and 12months following patient enrollment completion
Use echocardiography to measure the peak flow velocity.
baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(regurgitation)
Time Frame: baseline and 12months following patient enrollment completion
Evaluate the presence or absence of intravalvular or paravalvular regurgitation during the follow-up period by echocardiography.
baseline and 12months following patient enrollment completion
New York Heart Association Assessment (NYHA)
Time Frame: baseline and 12months following patient enrollment completion
Evaluate the New York Heart Association (NYHA) assessment to determine the improvement in cardiac function.The NYHA classification of heart function consists of four levels, ranging from Class I to Class IV, with heart function progressively deteriorating.
baseline and 12months following patient enrollment completion
Left ventricular ejection fraction(LVEF) change from baseline in postoperative echocardiographic
Time Frame: baseline and 12 months post-surgery
LVEF(%) change from baseline in postoperative echocardiography.
baseline and 12 months post-surgery
Left ventricular end-systolic diameter(LVESD) change from baseline in postoperative echocardiographic
Time Frame: baseline and 12 months post-surgery
LVESD(mm) change from baseline in postoperative echocardiography.
baseline and 12 months post-surgery
Left ventricular end-diastolic diameter(LVEDD) change from baseline in postoperative echocardiographic
Time Frame: baseline and 12 months post-surgery
LVEDD(mm) change from baseline in postoperative echocardiography.
baseline and 12 months post-surgery
BNP or NT-proBNP
Time Frame: baseline and 12 months following patient enrollment completion
Measure BNP or NT-proBNP to get the changes in postoperative cardiac function from baseline.
baseline and 12 months following patient enrollment completion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of device-related adverse events
Time Frame: 12months following patient enrollment completion
The incidence of device-related adverse events: Valve-related complications include moderate or greater structural valve degeneration, valve thrombosis, valve-related thromboembolism, severe bleeding (due to anticoagulant use), severe paravalvular leak, and prosthetic valve endocarditis.
12months following patient enrollment completion
Surgical adverse event rate
Time Frame: 12months following patient enrollment completion
Surgical adverse event rate: Surgical complications include severe lung infections, mediastinal or incision infections, postoperative severe hypotension, perioperative stroke, new-onset atrial fibrillation, new-onset complete atrioventricular block, acute kidney injury or worsening renal function requiring renal replacement therapy, severe bleeding, and cardiac tamponade.
12months following patient enrollment completion
Incidence of structural valve degeneration
Time Frame: 12months following patient enrollment completion
Incidence of structural valve degeneration: Structural valve degeneration refers to valve stenosis and/or regurgitation due to structural abnormalities of the valve itself (such as tearing, shedding, calcification, fibrosis, deformation of the valve frame, and rupture of the connecting parts between the valve components) as determined by reoperation or clinical examination (e.g., echocardiography, etc.).
12months following patient enrollment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Hearthill Medical Technology Co.,LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PoliaValve-SA-02

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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