Comparative Efficacy and Durability of Next-Generation Biological Aortic Prostheses.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Brazil
Instituto Dante Pazzanese de Cardiologia
RECRUITING
São Paulo
Contact Information
Primary
Tacianne Rolemberg Delamain, Master Degree
patricia.paiva@dantepazzanese.org.br
551150856353
Backup
Kleber Gomes Franchini, PhD
kleber.franchini@dantepazzanese.org.br
551150856353
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2036-12-01
Participants
Target number of participants: 200
Treatments
Experimental: Aortic Valve Replacement - Dafodil Prosthesis
Patients indicated for surgical aortic valve replacement will be randomized to receive the Dafodil prosthesis.
Active_comparator: Aortic Valve Replacement - Inspires Resilia prosthesis
Patients indicated for surgical aortic valve replacement will be randomized to receive Inspires Resilia prosthesis.
Related Therapeutic Areas
Sponsors
Leads: Instituto Dante Pazzanese de Cardiologia