Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06688448

Valvular Assessment of New Generation Aortic Replacement Devices

Led by Instituto Dante Pazzanese de Cardiologia · Updated on 2025-01-13

200

Participants Needed

1

Research Sites

626 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Valvular Assessment of New Generation Aortic Replacement Devices

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Eligible for surgical replacement of native aortic valve or re-replacement with a bioprosthetic valve in the aortic position
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil, 04012909

Actively Recruiting

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Research Team

T

Tacianne Rolemberg Delamain, Master Degree

CONTACT

K

Kleber Gomes Franchini, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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