Valvular Assessment of New Generation Aortic Replacement Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstituto Dante Pazzanese de Cardiologia
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 over their lifetimes.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Indicated for mechanical prosthetic valve replacement.
Require surgical intervention in another heart valve or transcatheter valve therapy.
Trial design
Treatments tested in this trial
- Dafodil prosthesis
- Aortic Valve Replacement - Inspires Resilia prosthesis
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov