Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Aortic Stenosis, Calcific
  • Aortic Valve Stenosis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

Description

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3/SAPIEN 3 Ultra THV or Clinical Surveillance.

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3/SAPIEN 3 Ultra THV or Clinical Surveillance.

Tracking Information

NCT #
NCT04889872
Collaborators
Not Provided
Investigators
Principal Investigator: Philippe Généreux, MD Morristown Medical Center, Morristown, NJ, USA Principal Investigator: Jeroen J Bax, MD, PhD Leiden University Medical Center, Leiden, The Netherlands Principal Investigator: Raj Makkar, MD Cedars-Sinai Medical Center, Los Angeles, CA, USA