Recruiting NCT07243184
The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mitral valve replacement.
- Who it may be relevant to
- Registry conditions: Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multicenter Clinical Trial Evaluating the Feasibility and Safety of Polymer Artificial Heart Valve for the Treatment of Mitral Valve Diseases
Overview
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.
Interventions
- Device mitral valve replacement
device: polymer artificial heart valve mitral valve replacement
Primary outcome measures
- The composite incidence rate of all-cause mortality and reoperation [Time frame: 3 months]
Secondary outcome measures (4)
- Implantation success rate [Time frame: after the operation]
- The change of 6 minutes walk testing(6MWT) from baseline [Time frame: 3months, 6months]
- Performance evaluation of implanted valves [Time frame: 1 day after operation, 7 days after operation, 1 months after operation, 3 months after operation.]
- The change of NYHA from basement [Time frame: 7 days after operation, 30 days after operation, 3 months after operation]
Eligibility criteria
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；
- 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)；
- 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);
- Confirmed or suspected diagnosis of infective endocarditis or other active infections;
- 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；
- Other situations in which patients are not suitable to participate in this trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anzhen Hospital — Beijing
Identifiers
NCT: NCT07243184 · HE2025SVMZG01