Severe Mitral Valve Regurgitation, Severe Mitral Valve StenosisHeartEpochNCT07243184
The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.
A study testing mitral valve replacement in people with Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis, run by Shanghai HeartEpoch Medical Technology Co., Ltd at 1 site in China.
Trial summary
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis
- What is being tested?
- mitral valve replacement
- 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
- 19 Nov 2025to Nov 2032
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 60 years old;
- severe mitral regurgitation or severe mitral stenosis confirmed by ECHO;
- surgical mitral valve replacement;
Who cannot join
- LVEF < 50%;
- History of cardiac surgery or history of cardiac intervention( within 1 year), Concurrent cardiac surgery(excluding tricuspid valve repair surgery or atrial fibrillation ablation) or cardiac interventional procedures;
- STS ≥8；
- intracardiac mass, thrombus or neoplasm confirmed by echo;
- Coronary artery disease that requires revascularization；
- A pacemaker need to be implanted;
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- Severe macrovascular lesions require surgical treatment;
- Patients with active bleeding, bleeding tendencies or those who are unable to receive anticoagulant therapy；
- There was evidence of acute myocardial infarction within 1 month before the surgery (Q-wave MI or non-Q-wave MI, CK-MB ≥ twice the normal level and/or elevated troponin)；
- here was a history of cerebrovascular events (CVA) within 1 month before the surgery, including ischemic and hemorrhagic strokes, but excluding transient ischemic attacks (TIA);
- Confirmed or suspected diagnosis of infective endocarditis or other active infections;
- There are diseases that significantly affect the evaluation of treatment, such as patients with neurological disorders that affect cognitive abilities, and patients with malignant tumors and an expected lifespan of no more than one year；
- Other situations in which patients 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.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing
Jian gang Wang, +8601064412431, jiangangwang@ccmu.edu.cn
About this study
Official title: A Prospective, Multicenter Clinical Trial Evaluating the Feasibility and Safety of Polymer Artificial Heart Valve for the Treatment of Mitral Valve Diseases
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
- Being tested
- mitral valve replacement
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve replacementDevice
device: polymer artificial heart valve mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Polymer Artificial Heart Valve | Experimental | Device: Polymer Artificial Heart Valve Mitral valve replacement Receives: Device: mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite incidence rate of all-cause mortality and reoperation
Measured: 3 months
Secondary outcomes (4)
Implantation success rate
Measured: after the operation
The change of 6 minutes walk testing(6MWT) from baseline
Measured: 3months, 6months
Performance evaluation of implanted valves
Measured: 1 day after operation, 7 days after operation, 1 months after operation, 3 months after operation.
The change of NYHA from basement
Measured: 7 days after operation, 30 days after operation, 3 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start19 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mitral Valve Regurgitation, Severe Mitral 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai HeartEpoch Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jiangang Wang, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243184
- Sponsor's protocol ID
- HE2025SVMZG01
- Acronym
- HeartEpoch
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Trial Evaluating the Feasibility and Safety of Polymer Artificial Heart Valve for the Treatment of Mitral Valve Diseases
- ClinicalTrials.gov ID
- NCT07243184
- Acronym / sponsor ID
- HeartEpoch / HE2025SVMZG01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai HeartEpoch Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 21 Nov 2025 (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 study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polymer Artificial Heart Valve | Experimental | Device: mitral valve replacementDevice: Polymer Artificial Heart Valve Mitral valve replacement |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 60 years old;
- severe mitral regurgitation or severe mitral stenosis confirmed by ECHO;
- surgical mitral valve replacement;
Key exclusion criteria (13 listed)
- LVEF < 50%;
- History of cardiac surgery or history of cardiac intervention( within 1 year), Concurrent cardiac surgery(excluding tricuspid valve repair surgery or atrial fibrillation ablation) or cardiac interventional procedures;
- STS ≥8；
- intracardiac mass, thrombus or neoplasm confirmed by echo;
- Coronary artery disease that requires revascularization；
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 |
|---|---|---|
| mitral valve replacementdevice: polymer artificial heart valve mitral valve replacement | Device | Polymer Artificial Heart Valve |
Primary outcome
The composite incidence rate of all-cause mortality and reoperation
Time frame: 3 months
4 secondary outcomes
Implantation success rate
Time frame: after the operation
The change of 6 minutes walk testing(6MWT) from baseline
Time frame: 3months, 6months
Performance evaluation of implanted valves
Time frame: 1 day after operation, 7 days after operation, 1 months after operation, 3 months after operation.
The change of NYHA from basement
Time frame: 7 days after operation, 30 days after operation, 3 months after operation
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 6 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral valve replacement in people with Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis, run by Shanghai HeartEpoch 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 3 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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?
Contact Jian Gang Wang (+8601064412431, Jiangangwang@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite incidence rate of all-cause mortality and reoperation (time frame: 3 months). 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 6 Jul 2026.