Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, Brazil, 04012909
Actively Recruiting
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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