Valvular Assessment of New Generation Aortic Replacement Devices

Recruiting now · Not applicable

Conditions studied: Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease

In brief

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.

Key facts

Study ID

NCT06688448

Run by

Instituto Dante Pazzanese de Cardiologia

People needed

200

Starts

2024-12-01

Expected to finish

2036-12-01

Last updated by the study team

2025-01-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Instituto Dante Pazzanese de Cardiologia — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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