Polymer artificial heart valve for mitral valve disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study evaluates a polymer artificial heart valve designed by Shanghai HeartEpoch Medical Technology for treating mitral valve disease. Eligible participants are patients aged 60 or older with severe mitral regurgitation or stenosis who are undergoing mitral valve replacement. The study focuses on safety and practicality of using the polymer valve in a mitral replacement setting at Beijing Anzhen Hospital. The primary goals are to assess device feasibility, perioperative safety, and short-term outcomes related to valve function. Enrollment is limited to sites in Beijing, with specific exclusion criteria to minimize surgical risk and ensure patient compatibility with the device.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anzhen Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jian Gang Wang
• Email: Jiangangwang@ccmu.edu.cn
• Phone: +8601064412431

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.