Aortic Valve StenosisNCT06737757
Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease
A study testing Artificial polymer heart valves and Bovine pericardial aortic valve in people with Aortic Valve Stenosis and Aortic Valve Disease, run by Suzhou Hearthill Medical Technology Co.,LTD.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Regurgitation
- What is being tested?
- Artificial polymer heart valves and Bovine pericardial aortic valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects are aged ≥18 years old;
- 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;
- The subjects have been confirmed to have severe aortic valve stenosis and/or regurgitation (also known as insufficiency) through echocardiography;
- 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.
Who cannot join
- 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;
- 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;
- 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;
- Preoperative decompensated heart failure, cardiogenic shock, malignant arrhythmias, etc., requiring mechanical circulatory support, mechanical ventilation, or emergency surgery;
- Active endocarditis within the past 3 months or the presence of cardiac vegetations;
- Severe acute myocardial infarction or history of cerebrovascular accidents within the past 3 months (excluding lacunar infarcts);
Show all 13Show fewer
- Severe renal insufficiency (glomerular filtration rate < 30mL/min) or end-stage renal disease requiring long-term dialysis;
- Liver dysfunction or gastrointestinal malnutrition-related diseases;
- Active bleeding, bleeding tendencies, or patients unable to receive anticoagulant therapy;
- Severe respiratory or ventilatory dysfunction requiring continuous oxygen therapy;
- 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;
- Other conditions with an expected lifespan of less than 1 year, such as malignancies and immunodeficiency diseases;
- Other situations not suitable for artificial aortic valve replacement or participation in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Artificial polymer heart valves, Bovine pericardial aortic valve
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial polymer heart valvesDevice
The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement
Bovine pericardial aortic valveDevice
The control group will undergo aortic valve replacement using bovine pericardial aortic valve
| Study group | Role | What they receive |
|---|---|---|
| Experimental group(PoliaValve) | Experimental | Using artificial polymer heart valves(PoliaValve, Hearthill Medical) for aortic valve replacement Receives: Device: Artificial polymer heart valves |
| Control Group | Active comparator | Using bovine pericardium aortic valve for aortic valve replacement Receives: Device: Bovine pericardial aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate without prosthetic valve events at 12 months post-surgery
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.
Measured: 12 months following patient enrollment completion
Secondary outcomes (10)
Surgical success rate
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.
Measured: 1 month following patient enrollment completion
Evaluation of postoperative artificial valve function(effective valve orifice area)
Use echocardiography to evaluate the effective valve orifice area to assess the hemodynamic Performance.
Measured: baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(mean transvalvular pressure gradient)
Use echocardiography to evaluate the mean transvalvular pressure gradient.
Measured: baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(peak flow velocity)
Use echocardiography to measure the peak flow velocity.
Measured: baseline and 12months following patient enrollment completion
Evaluation of postoperative artificial valve function(regurgitation)
Evaluate the presence or absence of intravalvular or paravalvular regurgitation during the follow-up period by echocardiography.
Measured: baseline and 12months following patient enrollment completion
New York Heart Association Assessment (NYHA)
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.
Measured: baseline and 12months following patient enrollment completion
Left ventricular ejection fraction(LVEF) change from baseline in postoperative echocardiographic
LVEF(%) change from baseline in postoperative echocardiography.
Measured: baseline and 12 months post-surgery
Left ventricular end-systolic diameter(LVESD) change from baseline in postoperative echocardiographic
LVESD(mm) change from baseline in postoperative echocardiography.
Measured: baseline and 12 months post-surgery
Left ventricular end-diastolic diameter(LVEDD) change from baseline in postoperative echocardiographic
LVEDD(mm) change from baseline in postoperative echocardiography.
Measured: baseline and 12 months post-surgery
BNP or NT-proBNP
Measure BNP or NT-proBNP to get the changes in postoperative cardiac function from baseline.
Measured: baseline and 12 months following patient enrollment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fanglin Lu, MD, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineXiangbin Pan, MD, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737757
- Sponsor's protocol ID
- PoliaValve-SA-02
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06737757
- Acronym / sponsor ID
- PoliaValve-SA-02
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Suzhou Hearthill Medical Technology Co.,LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group(PoliaValve) | Experimental | Device: Artificial polymer heart valvesUsing artificial polymer heart valves(PoliaValve, Hearthill Medical) for aortic valve replacement |
| Control Group | Active comparator | Device: Bovine pericardial aortic valveUsing bovine pericardium aortic valve for aortic valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subjects are aged ≥18 years old;
- 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;
- The subjects have been confirmed to have severe aortic valve stenosis and/or regurgitation (also known as insufficiency) through echocardiography;
- 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.
Key exclusion criteria (13 listed)
- 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;
- 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;
- 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;
- Preoperative decompensated heart failure, cardiogenic shock, malignant arrhythmias, etc., requiring mechanical circulatory support, mechanical ventilation, or emergency surgery;
- Active endocarditis within the past 3 months or the presence of cardiac vegetations;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial polymer heart valvesThe experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement | Device | Experimental group(PoliaValve) |
| Bovine pericardial aortic valveThe control group will undergo aortic valve replacement using bovine pericardial aortic valve | Device | Control Group |
Primary outcome
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.
10 secondary outcomes
Surgical success rate
Time frame: 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
Evaluation of postoperative artificial valve function(mean transvalvular pressure gradient)
Time frame: 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
Evaluation of postoperative artificial valve function(regurgitation)
Time frame: baseline and 12months following patient enrollment completion
New York Heart Association Assessment (NYHA)
Time frame: 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
Left ventricular end-systolic diameter(LVESD) change from baseline in postoperative echocardiographic
Time frame: 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
BNP or NT-proBNP
Time frame: baseline and 12 months following patient enrollment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fanglin Lu, MD study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Xiangbin Pan, MD study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Artificial polymer heart valves and Bovine pericardial aortic valve in people with Aortic Valve Stenosis and Aortic Valve Disease, run by Suzhou Hearthill Medical Technology Co.,LTD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanglin Lu, MD (86-021-63240090, drlufanglin@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate without prosthetic valve events at 12 months post-surgery (time frame: 12 months following patient enrollment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.