Valvular Assessment of New Generation Aortic Replacement Devices

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2036

Conditions
Aortic Regurgitation DiseaseAortic Valve CalcificationBicuspid Aortic Valve Disease
Interventions
DEVICE

Dafodil prosthesis

Surgical aortic valve replacement (SAVR) will be performed following standardized protocols to ensure consistency and optimize patient outcomes. Under general anesthesia, a median sternotomy will be conducted to access the aorta. Cardiopulmonary bypass (CPB) will be initiated, and the aorta will be cross-clamped to facilitate the safe removal of the existing prosthesis. After excising the deteriorated valve and removing any calcification, the new bioprosthetic valve will be implanted after randomized.

DEVICE

Aortic Valve Replacement - Inspires Resilia prosthesis

Surgical aortic valve replacement (SAVR) will be performed following standardized protocols to ensure consistency and optimize patient outcomes. Under general anesthesia, a median sternotomy will be conducted to access the aorta. Cardiopulmonary bypass (CPB) will be initiated, and the aorta will be cross-clamped to facilitate the safe removal of the existing prosthesis. After excising the deteriorated valve and removing any calcification, the new bioprosthetic valve will be implanted after randomized.

Trial Locations (1)

04012909

RECRUITING

Instituto Dante Pazzanese de Cardiologia, São Paulo

All Listed Sponsors
lead

Instituto Dante Pazzanese de Cardiologia

OTHER