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New treatment option for AORTIC VALVE DISEASES
Official title Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
ClinicalTrials.gov ID: NCT07097740
What this study is testing
- What it's testing
- The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement. The main question it aims to answer is: \-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Adults requiring surgical replacement of either mitral or aortic valve
- Capable of undergoing cardiopulmonary bypass
- Able to tolerate anticoagulation therapy
- Able to understand study purpose, willing to provide informed consent and comply with follow-up
You likely can't join if
- History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding...
- Requirement for urgent or emergency cardiac surgery.
- Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).
- Scheduled coronary artery bypass graft (CABG) during the same admission.
- Anticipated need for additional non-valve cardiac surgery within 12 months.
- Active systemic infection, including pneumonia or infective endocarditis.
See the full eligibility criteria
- Adults requiring surgical replacement of either mitral or aortic valve
- Capable of undergoing cardiopulmonary bypass
- Able to tolerate anticoagulation therapy
- Able to understand study purpose, willing to provide informed consent and comply with follow-up
- History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty [PBMV], which is permitted).
- Requirement for urgent or emergency cardiac surgery.
- Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).
- Scheduled coronary artery bypass graft (CABG) during the same admission.
- Anticipated need for additional non-valve cardiac surgery within 12 months.
- Active systemic infection, including pneumonia or infective endocarditis.
- Intracardiac thrombus detected on echocardiography or imaging.
- Stroke or transient ischemic attack within the prior 3 months.
- Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months.
- Severe comorbidities with expected life expectancy \<12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease.
- Participation in another treatment clinical trial involving investigational devices or drugs.
- Anatomical risk factors such as ascending aortic aneurysm (≥50 mm), bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk features identified on imaging.
- Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction.
- Severe renal insufficiency, e.g., estimated GFR \<30 mL/min/1.73 m² or requirement for chronic dialysis.
- Coagulopathy or active bleeding disorders, e.g., INR \>1.5 without anticoagulation therapy.
- Hematologic abnormalities: hematocrit \ 10 × 10⁹/L.
- History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance.
- Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure.
- Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis.
- Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.