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AORTIC VALVE DISEASESNCT07123766

Clinical Investigation for the PoliaValve Aortic Heart Valve- India

A study testing PoliaValve (Aortic) in people with AORTIC VALVE DISEASES and Aortic Valve Stenosis, run by Suzhou Hearthill Medical Technology Co.,LTD.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance. Read more about this study

Who is it for?
Ages 45 years and older
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
50 participants
Where
No sites listed yet
Study dates
15 Nov 2025to 30 Dec 2027
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is 45 years or older
  • Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
  • Agrees to attend all follow-up assessments for up to 1 year and is willing to comply with specified follow-up evaluations for the clinical trial
  • Diagnosed with severe symptomatic aortic valve stenosis and/or regurgitation

Who cannot join

  • Requires multiple valve replacement / repair
  • Requires emergency surgery
  • Has had prior valve surgery
  • Requires a surgical procedure outside of the cardiac area
  • Requires a cardiac procedure other than a CABG or root enlargement or aortic root replacement
  • Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device
Show all 25Show fewer
  • Has active endocarditis/myocarditis or within 3 months to the scheduled surgery
  • Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or end-stage renal disease requiring chronic dialysis at screening visit
  • Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery
  • Has acute myocardial infarction (AMI) within 30 days prior to planned valve surgery
  • Has life expectancy to less than 12 months
  • Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
  • Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
  • Echocardiographic left ventricular ejection fraction <25%
  • Echocardiographic evidence of an intra-cardiac thrombus or vegetation
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
  • Documented leukopenia (WBC < 4.0 x 103/µL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/µL) or history of bleeding diathesis or coagulopathy
  • Has prior organ transplant or is currently an organ transplant candidate
  • Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
  • Pregnant, lactating or planning to become pregnant during the duration of participation in trial
  • Currently incarcerated or unable to give voluntary informed consent
  • Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
  • Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump
  • Currently has uncontrolled infection
  • Currently diagnosed as uncontrolled diabetes mellitus (Random BLS > 300 mg/dl)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kevin Yan contact

(+86)021-68248839

kevin.yan@hearthillmedical.com

About this study

Official title: A Prospective, Multicenter, Single-Arm Study With Objective Performance Criteria Evaluating the Efficacy and Safety of PoliaValve® Artificial Heart Valve

The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.

Read the detailed description

The PoliaValve is indicated as a replacement for diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. The study is a single-arm, open label, non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 50 patients. These patients will follow the study schedule for 1 year after implantation.

Being tested
PoliaValve (Aortic)
Keywords
Heart Valve Diseases, Aortic Valve Regurgitation, Aortic Valve Disease, Polymeric Aortic Valve
Medical subject headings
Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Heart Valve Diseases

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 groups in NCT07123766
Study groupRoleWhat they receive
Experimental group(PoliaValve)ExperimentalPatients 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.

  1. Rate of Clinical Outcomes Events

    The rate of adverse events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature: a) thromboembolism, b) valve thrombosis, c) major paravalvular leak, d) major hemorrhage, e) endocarditis, f) all-caused death, g) valve related death, h) valve related reoperation, i) valve explant, j) hemorrhage, k) all-cause reoperation

    Measured: 12 months following patient enrollment completion

Secondary outcomes (11)

  1. Effective Orifice Area (EOA)

    Using doppler echocardiography to Measure Effective Orifice Area (EOA)

    Measured: 12 months following patient enrollment completion

  2. Mean Pressure Gradient(MPG)

    The mean pressure gradient (MPG) is a measure of the average pressure difference across a valve or a specific area in a fluid system, often measured by transthoracic echocardiogram.

    Measured: 12 months following patient enrollment completion

  3. New York Heart Association(NYHA) Improvement Assessment

    Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

    Measured: 12 months following patient enrollment completion

  4. Rate of Stroke

    Assessment of patient experiencing a stroke verified by imaging and or physical exam

    Measured: 12 months following patient enrollment completion

  5. Rate of Transient Ischemic Attack(TIA)

    Assessment of patient having a transient ischemic attack(TIA) verified by imaging and or physical exam

    Measured: 12 months following patient enrollment completion

  6. Intensive Care Unit(ICU) Duration of Stay

    Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes.

    Measured: 30 days post procedure

  7. Ventilation Time

    Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes

    Measured: 30 days post procedure

  8. Rate of New Onset Atrial Fibrillation

    Measured: 12 months post procedure

  9. Length of Stay in Hospital

    Measured: 30 days post procedure

  10. Readmission

    Patient readmission to the hospital post discharge measured by date/time

    Measured: 30 days post procedure

  11. Hemolysis screen

    Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments

    Measured: 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start15 Nov 2025 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07123766
Sponsor's protocol ID
PoliaValve-SA-03
Status last verified
Jul 2025
First submitted
28 Jul 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PoliaValve (Aortic) in people with AORTIC VALVE DISEASES and Aortic Valve Stenosis, 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 25 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 14 Aug 2025. 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 Kevin Yan ((+86)021-68248839, kevin.yan@hearthillmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Clinical Outcomes Events (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?

On the ClinicalTrials.gov record for NCT07123766.

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 14 Aug 2025.

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