RecruitingNot ApplicableNCT06688448

Valvular Assessment of New Generation Aortic Replacement Devices

Comparative Efficacy and Durability of Next-Generation Biological Aortic Prostheses.

Sponsor

Instituto Dante Pazzanese de Cardiologia

Enrollment

200 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Regurgitation Disease Aortic Valve Calcification Bicuspid Aortic Valve Disease

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

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 Criteria2

Indicated for mechanical prosthetic valve replacement.
Require surgical intervention in another heart valve or transcatheter valve therapy.

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Interventions

DEVICEDafodil prosthesis

Surgical aortic valve replacement (SAVR) will be performed following standardized protocols to ensure consistency and optimize patient outcomes. Under general anesthesia, a median sternotomy will be conducted to access the aorta. Cardiopulmonary bypass (CPB) will be initiated, and the aorta will be cross-clamped to facilitate the safe removal of the existing prosthesis. After excising the deteriorated valve and removing any calcification, the new bioprosthetic valve will be implanted after randomized.

DEVICEAortic Valve Replacement - Inspires Resilia prosthesis