Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease

Launched by CLOSED JOINT-STOCK COMPANY NEOCOR · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new type of heart valve replacement called the "UniLine" biological prosthesis, which is designed to treat diseases affecting the aortic and mitral valves of the heart. These valve diseases can lead to serious health problems, and the goal of the trial is to see if the UniLine prosthesis can improve survival rates and reduce the chance of needing further surgeries. Researchers will look at how well the prosthesis works over time, its safety, and how long it lasts, as well as measure important blood flow parameters to ensure it functions properly.

To participate in this study, individuals must be at least 18 years old and have had a replacement of either the mitral or aortic valve using the UniLine prosthesis for the first time (no previous heart valve replacements). Patients with other heart valve replacements, certain types of heart repairs, or active cancer are not eligible. Participants will undergo regular check-ups, including heart ultrasound tests, to monitor their progress. The study is currently recruiting patients, and it is being conducted at the Research Institute of Complex Issues of Cardiovascular Diseases, which has received the necessary approvals to carry out this important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of both sexes aged 18 years and older who underwent isolated mitral or aortic valve replacement using the "UniLine" bioprosthesis
• • No prior heart valve replacement
• Exclusion Criteria:
• • The presence of a mechanical or biological prosthesis in another position
• • Prior valve repair
• • Aortic aneurysm repair (ascending aorta)
• • Resection of a left ventricular aneurysm
• • Patients with active cancer and patients with history of cancer