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Clinical Trials in China / NCT07243184
Recruiting Not applicable

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

NCT07243184 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai HeartEpoch Medical Technology Co., Ltd
Phase
Not applicable
Started
2025-11-19
Last updated
2026-07-06

Condition(s) studied

Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis

Investigational drug(s) / intervention(s)

mitral valve replacement

mitral valve replacement: device: polymer artificial heart valve mitral valve replacement

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. ≥ 60 years old; 2. severe mitral regurgitation or severe mitral 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Anzhen Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07243184 on ClinicalTrials.gov ↗ ← All trials in China