Plastic heart valve? small trial tests polymer replacement for mitral valve disease
NCT ID NCT07243184
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This early study will test a new polymer artificial heart valve in 10 people aged 60 or older with severe mitral valve disease. The goal is to see if the valve is safe and can be implanted successfully. Researchers will track deaths, reoperations, and how well patients can walk after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- polymer artificial heart valve
- What this could lead to
- If successful, this could lead to a more durable and safer artificial heart valve option for people with mitral valve disease.
- What could go wrong
- This is a very small early feasibility study with only 10 participants, so results may not apply widely. The valve may fail or cause complications, and long-term safety is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Anzhen Hospital
RECRUITINGBeijing, China