RecruitingNot Applicable

Valvular Assessment of New Generation Aortic Replacement Devices

Brazil200 participantsStarted 2024-12-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Rate of bioprosthetic valve deterioration

Timeframe: 12 months

Trial details

NCT IDNCT06688448

SponsorInstituto Dante Pazzanese de Cardiologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Tacianne Rolemberg Delamain, Master Degree

551150856353 patricia.paiva@dantepazzanese.org.br

View on ClinicalTrials.gov More Aortic Regurgitation Disease trials