Surgical implantation of a polymer prosthetic mitral or aortic valve

A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve

This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Mitrassist Lifesciences Limited Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07097740 on ClinicalTrials.gov

What this trial studies

This is a prospective, exploratory, single-center study that will enroll 10 adults requiring either mitral or aortic valve replacement, with five patients in each valve group. Participants will undergo surgical implantation of an investigational polymer prosthetic valve and attend follow-up visits at 30 days, 3–6 months, and 12 months for clinical event monitoring and echocardiography. The primary endpoint is the rate of valve-related complications at 12 months, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis. Secondary endpoints include immediate device success, valve hemodynamics, comprehensive safety events (e.g., mortality, reoperation, valve extraction, structural or non-structural dysfunction), NYHA class, and KCCQ quality-of-life measures.

Who should consider this trial

Good fit: Adults who require surgical replacement of the mitral or aortic valve, can undergo cardiopulmonary bypass and anticoagulation, and meet the trial's inclusion and exclusion criteria are the intended participants.

Not a fit: Patients with prior valve replacement, active systemic infection, intracardiac thrombus, urgent/emergency surgical needs, planned combined procedures, or significant comorbidities are unlikely to qualify and may not benefit from this approach.

Why it matters

Potential benefit: If successful, the polymer valve could provide an alternative to mechanical and tissue valves with a potentially different balance of durability and complication risk.

How similar studies have performed: Polymer prosthetic valves are an emerging and relatively novel approach with limited human data, whereas mechanical and bioprosthetic valves have well-established clinical outcome data.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

1. 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).
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).

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lai Wei, MD

Conditions AORTIC VALVE DISEASES; Mitral Valve Disease; Aortic Stenosis; Aortic Regurgitation; Mitral Stenosis; Mitral Regurgitation