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

NCT ID: NCT07243184

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2032-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Polymer Artificial Heart Valve

Device: Polymer Artificial Heart Valve Mitral valve replacement

Group Type: EXPERIMENTAL

mitral valve replacement

Intervention Type: DEVICE

device: polymer artificial heart valve mitral valve replacement

Interventions

mitral valve replacement

device: polymer artificial heart valve mitral valve replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. ≥ 60 years old;

2. severe aortic regurgitation or severe aortic stenosis confirmed by ECHO;

3. surgical mitral valve replacement;

Exclusion Criteria

1. LVEF < 50%;

2. 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;

3. STS ≥8；

4. intracardiac mass, thrombus or neoplasm confirmed by echo;

5. Coronary artery disease that requires revascularization；

6. A pacemaker need to be implanted;

7. Severe macrovascular lesions require surgical treatment;

8. Patients with active bleeding, bleeding tendencies or those who are unable to receive anticoagulant therapy；

9. 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)；

10. 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);

11. Confirmed or suspected diagnosis of infective endocarditis or other active infections;

12. 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；

13. Other situations in which patients are not suitable to participate in this trial.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai HeartEpoch Medical Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Jiangang Wang

Director of valve and AF surgical center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HE2025SVMZG01

Identifier Type: -

Identifier Source: org_study_id