PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Last updated on July 2021Recruitment
- 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