Valvular Assessment of New Generation Aortic Replacement Devices

The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement (AVR). This study aims to provide robust data on valve durability, safety, and hemodynamic performance, particularly in younger patients who may require multiple interventions over their lifetimes.

NCT Number	NCT06688448
Lead Sponsor	Instituto Dante Pazzanese de Cardiologia
Conditions	Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
Enrollment	200 participants
Start Date	2024-12-01
Primary Completion	2026-12-01 (estimated)
Study Completion	2036-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-01-13