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

A Prospective, Multicenter Clinical Trial Evaluating the Feasibility and Safety of Polymer Artificial Heart Valve for the Treatment of Mitral Valve Diseases

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mital Valve Disease
• Intervention / Treatment: Device: mitral valve replacement

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polymer Artificial Heart Valve; Device: Polymer Artificial Heart Valve Mitral valve replacement	Device: mitral valve replacement; device: polymer artificial heart valve mitral valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The composite incidence rate of all-cause mortality and reoperation	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai HeartEpoch Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HE2025SVMZG01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No