Aortic Valve DiseaseNCT06518681
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
A study testing PoliaValve (Aortic) in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Suzhou Hearthill Medical Technology Co.,LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- What is being tested?
- PoliaValve (Aortic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 30 Dec 2025
- 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
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Clinical Trial Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
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.
Read the 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.
- Being tested
- PoliaValve (Aortic)
- Keywords
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Ventricular Outflow Obstruction, Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Regurgitation
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Ventricular Outflow Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoliaValve (Aortic)Device
Aortic Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| PoliaValve (Aortic) | Experimental | Patients receiving the PoliaValve (Aortic) from HearrHill Medical Receives: Device: PoliaValve (Aortic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month following patient enrollment completion
Secondary outcomes (6)
EOA
Use echocardiography to evaluate the effective valve orifice area(EOA) to assess the hemodynamic Performance.
Measured: baseline and 1 month, 6months, 12months following patient enrollment completion
Mean transvalvular pressure difference
Use echocardiography to measure the mean transvalvular pressure difference.
Measured: baseline and 1 month, 6months, 12months following patient enrollment completion
Peak flow velocity
Use echocardiography to measure the peak flow velocity.
Measured: baseline and 1 month, 6months, 12months following patient enrollment completion
Regurgitation
Evaluate the presence or absence of intravalvular or paravalvular regurgitation during the follow-up period by echocardiography.
Measured: baseline and 1 month, 6months, 12months following patient enrollment completion
New York Heart Association Assessment (NYHA)
Evaluate New York Heart Association Assessment (NYHA) to see Heart Function Improvement.
Measured: baseline and 1 month, 6months, 12months following patient enrollment completion
BNP or NT-proBNP
Measure BNP or NT-proBNP to get the changes in postoperative cardiac function from baseline.
Measured: baseline and 1 month, 12months 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 posted24 Jul 2024
- Study start15 Aug 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518681
- Sponsor's protocol ID
- PoliaValve-SA-01
- Status last verified
- Dec 2024
- First submitted
- 4 Jun 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT06518681
- Acronym / sponsor ID
- PoliaValve-SA-01
- Keywords
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Ventricular Outflow Obstruction, Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Suzhou Hearthill Medical Technology Co.,LTDIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PoliaValve (Aortic) | Experimental | Device: PoliaValve (Aortic)Patients receiving the PoliaValve (Aortic) from HearrHill Medical |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
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 |
|---|---|---|
| PoliaValve (Aortic)Aortic Valve Replacement | Device | PoliaValve (Aortic) |
Primary outcome
Compliance rate of prosthetic valve function
Time frame: 1 month following patient enrollment completion
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.
Surgery success rate
Time frame: 1 month following patient enrollment completion
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.
6 secondary outcomes
EOA
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
Mean transvalvular pressure difference
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
Peak flow velocity
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
Regurgitation
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
New York Heart Association Assessment (NYHA)
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
BNP or NT-proBNP
Time frame: baseline and 1 month, 12months 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 16 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PoliaValve (Aortic) in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Suzhou Hearthill Medical Technology Co.,LTD at 1 site in China.
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 5 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate of prosthetic valve function (time frame: 1 month following patient enrollment completion). The study lists 2 primary outcomes in all. 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 16 Dec 2024.