Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

August 8, 2017

Primary Completion Date

October 30, 2023

Study Completion Date

May 30, 2024

Conditions
Degenerative Aortic Valve DiseaseAortic StenosisAortic Regurgitation
Interventions
PROCEDURE

Edwards

The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).

PROCEDURE

CoreValve

The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).

PROCEDURE

Acurate neo

The TAVR procedure will be performed with the ACURATE neo aortic valve.

PROCEDURE

Standard

The choice of the type and size of valve, utilization of additional procedures such as root enlargement will be left at the discretion of heart team of the treating the patient.

Trial Locations (1)

G1V 4G5

IUCPQ, Québec

All Listed Sponsors
lead

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

OTHER

NCT03383445 - Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial | Biotech Hunter | Biotech Hunter