Valvular Assessment of New Generation Aortic Replacement Devices

Launched by INSTITUTO DANTE PAZZANESE DE CARDIOLOGIA · Nov 12, 2024

Keywords

ClinConnect Summary

The VANGUARD study is a clinical trial looking at two new types of heart valves, called Dafodil® and INSPIRIS Resilia®, that are used to replace damaged aortic valves in the heart. The trial aims to understand how well these valves work over a long period of time, especially for younger patients who may need more surgeries in their lives. Researchers will compare the durability, safety, and performance of these valves in patients who have conditions like aortic regurgitation or calcification.

To participate in this study, you need to be between 18 and 65 years old and be scheduled for surgery to replace a damaged aortic valve. However, if you require a different type of valve or have other heart surgeries planned at the same time, you may not be eligible. If you join the study, you will receive one of the two valves and be monitored to help gather important information about how well it performs. This research is crucial for improving heart valve treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 18 to 65 years.
• • Eligible for surgical replacement of native valve or re-replacement of a prosthetic valve with a bioprosthetic valve in the aortic position.
• Exclusion Criteria:
• • Indicated for mechanical prosthetic valve replacement.
• • Require surgical intervention in another heart valve or transcatheter valve therapy.