RecruitingNot Applicable

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

China10 participantsStarted 2025-11-19

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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；

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The composite incidence rate of all-cause mortality and reoperation

Timeframe: 3 months

Trial details

NCT IDNCT07243184

SponsorShanghai HeartEpoch Medical Technology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Jian Gang Wang

+8601064412431 Jiangangwang@ccmu.edu.cn

View on ClinicalTrials.gov More Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis trials