The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.

NCT07243184 | Not Yet Recruiting

• 1 other identifier: HE2025SVMZG01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Mital Valve Disease

Outcome Measures

Primary Outcomes (1)

• The composite incidence rate of all-cause mortality and reoperation

  3 months

Secondary Outcomes (4)

• Implantation success rate

  after the operation

• The improvement of 6 minutes walk testing(6MWT) from baseline

  3months, 6months

• Performance evaluation of implanted valves

  1 day after operation, 7 days after operation, 1 months after operation, 3 months after operation.

• The improvement of NYHA from basement

  7 days after operation, 30 days after operation, 3 months after operation

Study Arms (1)

Polymer Artificial Heart Valve

EXPERIMENTAL

Device: Polymer Artificial Heart Valve Mitral valve replacement

Device: mitral valve replacement

Interventions

mitral valve replacement DEVICE

device: polymer artificial heart valve mitral valve replacement

Polymer Artificial Heart Valve

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 60 years old;
• severe aortic regurgitation or severe aortic stenosis confirmed by ECHO;
• surgical mitral valve replacement;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai HeartEpoch Medical Technology Co., Ltd: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of valve and AF surgical center

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2032
• Last Updated: November 21, 2025

Record last verified: 2025-11