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Valvular Assessment of New Generation Aortic Replacement Devices

RecruitingNAAges 18 Years - 65 YearsAllInstituto Dante Pazzanese de Cardiologia
NCT06688448 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Dafodil prosthesis
  • Aortic Valve Replacement - Inspires Resilia prosthesis
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Where

1 site
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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