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New treatment option for Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis
Official title The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.
ClinicalTrials.gov ID: NCT07243184
What this study is testing
- What it's testing
- The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- ≥ 60 years old;
- severe mitral regurgitation or severe mitral stenosis confirmed by ECHO;
- surgical mitral valve replacement;
You likely can't join if
- LVEF \< 50%;
- History of cardiac surgery or history of cardiac intervention( within 1 year), Concurrent cardiac surgery(excluding tricuspid valve repair surgery or...
- STS ≥8；
- intracardiac mass, thrombus or neoplasm confirmed by echo;
- Coronary artery disease that requires revascularization；
- A pacemaker need to be implanted;
See the full eligibility criteria
- ≥ 60 years old;
- severe mitral regurgitation or severe mitral stenosis confirmed by ECHO;
- surgical mitral valve replacement;
- 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 treatment 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...
- Other situations in which patients are not suitable to participate in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.