Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
NCT ID: NCT07097740
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-06-27
2027-06-30
Brief Summary
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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
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
* Polymer Aortic Valve Replacement
* Polymer Mitral Valve Replacement
TREATMENT
NONE
Study Groups
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Polymer Aortic Valve Replacement
Surgical implantation of polymer prosthetic valve in the aortic position.
Polymer Prosthetic Heart Valve
Surgical implantation of polymer prosthetic valve.
Polymer Mitral Valve Replacement
Surgical implantation of polymer prosthetic valve in the mitral position.
Polymer Prosthetic Heart Valve
Surgical implantation of polymer prosthetic valve.
Interventions
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Polymer Prosthetic Heart Valve
Surgical implantation of polymer prosthetic valve.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
2. Requirement for urgent or emergency cardiac surgery.
3. Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).
4. Scheduled coronary artery bypass graft (CABG) during the same admission.
5. Anticipated need for additional non-valve cardiac surgery within 12 months.
6. Active systemic infection, including pneumonia or infective endocarditis.
7. Intracardiac thrombus detected on echocardiography or imaging.
8. Stroke or transient ischemic attack within the prior 3 months.
9. Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months.
10. Severe comorbidities with expected life expectancy \<12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease.
11. Participation in another interventional clinical trial involving investigational devices or drugs.
12. 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.
13. Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction.
14. Severe renal insufficiency, e.g., estimated GFR \<30 mL/min/1.73 m² or requirement for chronic dialysis.
15. Coagulopathy or active bleeding disorders, e.g., INR \>1.5 without anticoagulation therapy.
16. Hematologic abnormalities: hematocrit \<30%, hemoglobin \<100 g/L, platelet count \<100 × 10⁹/L, or WBC \<4 × 10⁹/L or \>10 × 10⁹/L.
17. History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance.
18. Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure.
19. Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis.
20. Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll).
50 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Mitrassist Lifesciences Limited Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Chunming Du, Medical Master
Role: CONTACT
Facility Contacts
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Lai Wei, MD
Role: primary
Other Identifiers
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PSVR-FIH-ZS
Identifier Type: -
Identifier Source: org_study_id