Early Study of Surgical Implantation of a Polymer Prosthetic Heart Valve for Mitral and Aortic Valve Replacement in Adults

What this Trial Is About

Researchers are evaluating the early feasibility, safety, and effectiveness of surgically implanting a polymer prosthetic heart valve in patients who need either mitral or aortic valve replacement. This exploratory study will include 10 patients, with 5 receiving the valve in the mitral position and 5 in the aortic position. The main focus is to measure valve-related complications such as thromboembolism, valve thrombosis, severe leaks, severe bleeding, and infections within 12 months after surgery. Participants will undergo surgical implantation of the polymer prosthetic valve in either the mitral or aortic position according to their group. Follow-up visits are scheduled at 30 days, between 3 to 6 months, and at 12 months after the operation to assess clinical outcomes. These assessments include echocardiographic evaluations and monitoring for clinical events related to the valve and heart function. During the study, participants will have multiple assessments including heart function classification, valve performance measurements like blood flow gradients and leakage severity, and quality of life questionnaires. Safety monitoring will cover all-cause mortality, reoperations, and valve function over the 12-month period. The study aims to provide data on initial device success and comprehensive safety outcomes, with total participation lasting at least one year following valve implantation.

Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve