Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
Recruiting
N/A
Interventional Study
AORTIC VALVE DISEASES
Mitral Valve Disease
Aortic Stenosis
Aortic Regurgitation
Mitral Stenosis
Mitral Regurgitation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd. · Industry
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About This Trial
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 perivalvula…
Trial Locations
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Eligibility Criteria
Inclusion 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
Exclusion Criteri…
Contacts
Chunming Du, Medical Master
CONTACT