Valvular Assessment of New Generation Aortic Replacement Devices
Recruiting
N/A
Interventional Study
Aortic Regurgitation Disease
Aortic Valve Calcification
Bicuspid Aortic Valve Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Instituto Dante Pazzanese de Cardiologia · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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…
Contacts
Tacianne Rolemberg Delamain, Master Degree
551150856353
patricia.paiva@dantepazzanese.org.br
CONTACT