Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve

NCT07097740 | Recruiting

• 1 other identifier: PSVR-FIH-ZS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months post-operation

Secondary Outcomes (7)

• Immediate Device Success Rate

  Immediately post-operation

• Valve Hemodynamic Performance 1 Mean Transvalvular Gradient at 12 months

  12 months post-operation

• Valve Hemodynamic Performance2 Effective Orifice Area (EOA) at 12 months

  12 months post-operation

• Safety Outcomes and Adverse Events

  Up to 12 months post-operation

• Cardiac Function Classification (NYHA)

  12 months post-operation

Study Arms (2)

Polymer Aortic Valve Replacement

EXPERIMENTAL

Surgical implantation of polymer prosthetic valve in the aortic position.

Device: Polymer Prosthetic Heart Valve

Polymer Mitral Valve Replacement

EXPERIMENTAL

Surgical implantation of polymer prosthetic valve in the mitral position.

Device: Polymer Prosthetic Heart Valve

Interventions

Polymer Prosthetic Heart Valve DEVICE

Surgical implantation of polymer prosthetic valve.

Polymer Aortic Valve Replacement; Polymer Mitral Valve Replacement

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mitrassist Lifesciences Limited Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Stenosis; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Lai Wei, MD

CONTACT

021-51371990; wei.lai@zs-hospital.sh.cn

Chunming Du, Medical Master

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of two parallel intervention groups: * Polymer Aortic Valve Replacement * Polymer Mitral Valve Replacement

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 31, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CN (1)