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Valvular Assessment of New Generation Aortic Replacement Devices

RECRUITINGN/ASponsored by Instituto Dante Pazzanese de Cardiologia
Actively Recruiting
PhaseN/A
SponsorInstituto Dante Pazzanese de Cardiologia
Started2024-12-01
Est. completion2026-12-01
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06688448

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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.

Conditions4

Aortic Regurgitation DiseaseAortic Valve CalcificationBicuspid Aortic Valve DiseaseHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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