The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

December 23, 2019

Study Completion Date

January 21, 2025

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV

Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.

Trial Locations (6)

Unknown

St. Paul's Hospital, Vancouver

Hamilton Health Sciences, Hamilton

Toronto General Hospital, Toronto

Institut universitaire de cardiologie et de pneumologie de Québec, Québec

Kings Hospital, London

St. Thomas Hospital, London

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY