AORTIC VALVE DISEASESPOLYVALVE-FIHNCT07097740
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
A study testing Polymer Prosthetic Heart Valve in people with AORTIC VALVE DISEASES and Mitral Valve Disease, run by Mitrassist Lifesciences Limited Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis
- What is being tested?
- Polymer Prosthetic Heart Valve
- 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
- 27 Jun 2025to Jun 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults requiring surgical replacement of either mitral or aortic valve
- Capable of undergoing cardiopulmonary bypass
- Able to tolerate anticoagulation therapy
- Able to understand study purpose, willing to provide informed consent and comply with follow-up
Who cannot join
- History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty [PBMV], which is permitted).
- Requirement for urgent or emergency cardiac surgery.
- Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).
- Scheduled coronary artery bypass graft (CABG) during the same admission.
- Anticipated need for additional non-valve cardiac surgery within 12 months.
- Active systemic infection, including pneumonia or infective endocarditis.
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- Intracardiac thrombus detected on echocardiography or imaging.
- Stroke or transient ischemic attack within the prior 3 months.
- Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months.
- Severe comorbidities with expected life expectancy <12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease.
- Participation in another interventional clinical trial involving investigational devices or drugs.
- Anatomical risk factors such as ascending aortic aneurysm (≥50 mm), bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk features identified on imaging.
- Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction.
- Severe renal insufficiency, e.g., estimated GFR <30 mL/min/1.73 m² or requirement for chronic dialysis.
- Coagulopathy or active bleeding disorders, e.g., INR >1.5 without anticoagulation therapy.
- Hematologic abnormalities: hematocrit <30%, hemoglobin <100 g/L, platelet count <100 × 10⁹/L, or WBC <4 × 10⁹/L or >10 × 10⁹/L.
- History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance.
- Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure.
- Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis.
- Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chunming Du, Medical Master contact
China1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Lai Wei, MD, 021-51371990, wei.lai@zs-hospital.sh.cn
Chunsheng Wang, MD
About this study
Official title: A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement.
The main question it aims to answer is:
Read more
-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation?
Participants will undergo:
- Surgical implantation of a polymer prosthetic valve (mitral valve replacement for mitral valve group and aortic valve replacement for aortic valve group).
- Regular follow-up visits at 30 days, 3-6 months, and 12 months post-operation to evaluate clinical outcomes, including echocardiographic assessment and clinical event monitoring.
Read the detailed description
This is a prospective, exploratory, single-center clinical study designed to assess the early feasibility and initial safety of an investigational polymer prosthetic heart valve. A total of 10 patients will be enrolled, with 5 patients assigned to the mitral valve replacement group and 5 patients to the aortic valve replacement group.
Primary outcomes include the occurrence of valve-related complications within 12 months, such as thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis.
Secondary outcomes include immediate device success rate, valve hemodynamic performance, comprehensive safety event evaluations (e.g., all-cause mortality, all-cause reoperation, valve extraction, and structural or non-structural valve dysfunction), cardiac functional classification (NYHA), and quality of life assessments (Kansas City Cardiomyopathy Questionnaire, KCCQ).
Eligible participants are patients requiring mitral or aortic valve replacement, capable of undergoing extracorporeal circulation and anticoagulation therapy, and who have provided informed consent.
Exclusion criteria include patients with prior valve replacement surgery (except transcatheter mitral valve edge-to-edge repair), urgent/emergency procedures, significant comorbidities (e.g., recent stroke or myocardial infarction, severe liver/kidney dysfunction, active infections), severe coagulation disorders, allergies to valve materials, substance abuse issues, psychiatric disorders, or anticipated life expectancy under 12 months. Patients who drop out after valve implantation will not be replaced.
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation, Mitral Stenosis, Mitral Regurgitation
- Being tested
- Polymer Prosthetic Heart Valve
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Stenosis, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymer Prosthetic Heart ValveDevice
Surgical implantation of polymer prosthetic valve.
| Study group | Role | What they receive |
|---|---|---|
| Polymer Aortic Valve Replacement | Experimental | Surgical implantation of polymer prosthetic valve in the aortic position. Receives: Device: Polymer Prosthetic Heart Valve |
| Polymer Mitral Valve Replacement | Experimental | Surgical implantation of polymer prosthetic valve in the mitral position. Receives: Device: Polymer Prosthetic Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Incidence of Valve-related Complications
Evaluate the incidence of valve-related complications at 12 months post-operation, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis.
Measured: 12 months post-operation
Secondary outcomes (7)
Immediate Device Success Rate
Proportion of participants achieving successful device implantation without intraoperative complications.
Measured: Immediately post-operation
Valve Hemodynamic Performance 1 Mean Transvalvular Gradient at 12 months
Mean pressure gradient across the valve measured by echocardiography (unit: mmHg).
Measured: 12 months post-operation
Valve Hemodynamic Performance2 Effective Orifice Area (EOA) at 12 months
Effective orifice area of the implanted valve measured by echocardiography (unit: cm²).
Measured: 12 months post-operation
Safety Outcomes and Adverse Events
Incidence of safety-related events including all-cause mortality, all-cause reoperation, valve extraction, valve thrombosis, severe bleeding, severe perivalvular leak, structural and non-structural valve deterioration, hemolysis, endocarditis, and any other serious adverse events.
Measured: Up to 12 months post-operation
Cardiac Function Classification (NYHA)
Assess participants' cardiac function using New York Heart Association (NYHA) classification.
Measured: 12 months post-operation
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score at 12 months
Quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The KCCQ is a 23-item questionnaire measuring health status in heart failure patients, scored from 0 to 100, where higher scores indicate a better health status.
Measured: 12 months post-operation
Valve Hemodynamic Performance 3 Paravalvular Leakage Severity at 12 months
Severity of paravalvular leakage (PVL) assessed by echocardiography, classified as None/Trace, Mild, Moderate, or Severe.
Measured: 12 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start27 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AORTIC VALVE DISEASESStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two parallel intervention groups: * Polymer Aortic Valve Replacement * Polymer Mitral Valve Replacement
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097740
- Sponsor's protocol ID
- PSVR-FIH-ZS
- Acronym
- POLYVALVE-FIH
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve
- ClinicalTrials.gov ID
- NCT07097740
- Acronym / sponsor ID
- POLYVALVE-FIH / PSVR-FIH-ZS
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation, Mitral Stenosis, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mitrassist Lifesciences Limited Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Jul 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 goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement.
The main question it aims to answer is:
-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation?
Participants will undergo:
- Surgical implantation of a polymer prosthetic valve (mitral valve replacement for mitral valve group and aortic valve replacement for aortic valve group).
- Regular follow-up visits at 30 days, 3-6 months, and 12 months post-operation to evaluate clinical outcomes, including echocardiographic assessment and clinical event monitoring.
Detailed description
This is a prospective, exploratory, single-center clinical study designed to assess the early feasibility and initial safety of an investigational polymer prosthetic heart valve. A total of 10 patients will be enrolled, with 5 patients assigned to the mitral valve replacement group and 5 patients to the aortic valve replacement group.
Primary outcomes include the occurrence of valve-related complications within 12 months, such as thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis.
Secondary outcomes include immediate device success rate, valve hemodynamic performance, comprehensive safety event evaluations (e.g., all-cause mortality, all-cause reoperation, valve extraction, and structural or non-structural valve dysfunction), cardiac functional classification (NYHA), and quality of life assessments (Kansas City Cardiomyopathy Questionnaire, KCCQ).
Eligible participants are patients requiring mitral or aortic valve replacement, capable of undergoing extracorporeal circulation and anticoagulation therapy, and who have provided informed consent.
Exclusion criteria include patients with prior valve replacement surgery (except transcatheter mitral valve edge-to-edge repair), urgent/emergency procedures, significant comorbidities (e.g., recent stroke or myocardial infarction, severe liver/kidney dysfunction, active infections), severe coagulation disorders, allergies to valve materials, substance abuse issues, psychiatric disorders, or anticipated life expectancy under 12 months. Patients who drop out after valve implantation will not be replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two parallel intervention groups: * Polymer Aortic Valve Replacement * Polymer Mitral Valve Replacement
| Arm | Type | Receives |
|---|---|---|
| Polymer Aortic Valve Replacement | Experimental | Device: Polymer Prosthetic Heart ValveSurgical implantation of polymer prosthetic valve in the aortic position. |
| Polymer Mitral Valve Replacement | Experimental | Device: Polymer Prosthetic Heart ValveSurgical implantation of polymer prosthetic valve in the mitral position. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults requiring surgical replacement of either mitral or aortic valve
- Capable of undergoing cardiopulmonary bypass
- Able to tolerate anticoagulation therapy
- Able to understand study purpose, willing to provide informed consent and comply with follow-up
Key exclusion criteria (20 listed)
- History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty [PBMV], which is permitted).
- Requirement for urgent or emergency cardiac surgery.
- Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).
- Scheduled coronary artery bypass graft (CABG) during the same admission.
- Anticipated need for additional non-valve cardiac surgery within 12 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 |
|---|---|---|
| Polymer Prosthetic Heart ValveSurgical implantation of polymer prosthetic valve. | Device | Polymer Aortic Valve Replacement, Polymer Mitral Valve Replacement |
Primary outcome
12-Month Incidence of Valve-related Complications
Time frame: 12 months post-operation
Evaluate the incidence of valve-related complications at 12 months post-operation, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis.
7 secondary outcomes
Immediate Device Success Rate
Time frame: Immediately post-operation
Valve Hemodynamic Performance 1 Mean Transvalvular Gradient at 12 months
Time frame: 12 months post-operation
Valve Hemodynamic Performance2 Effective Orifice Area (EOA) at 12 months
Time frame: 12 months post-operation
Safety Outcomes and Adverse Events
Time frame: Up to 12 months post-operation
Cardiac Function Classification (NYHA)
Time frame: 12 months post-operation
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score at 12 months
Time frame: 12 months post-operation
Valve Hemodynamic Performance 3 Paravalvular Leakage Severity at 12 months
Time frame: 12 months post-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 31 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Chunming Du, Medical Master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymer Prosthetic Heart Valve in people with AORTIC VALVE DISEASES and Mitral Valve Disease, run by Mitrassist Lifesciences Limited 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 4 inclusion and 20 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 31 Jul 2025. 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 Lai Wei, MD (021-51371990, wei.lai@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Month Incidence of Valve-related Complications (time frame: 12 months post-operation). 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 31 Jul 2025.