SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Valve Replacement
- Aortic Valve Stenosis
- Symptomatic Aortic Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a prospective, multi-center, international, randomized controlled, post-market trial. The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+ System when compared to subjects treated with the SAPIEN 3/3 Ultra System a...
This is a prospective, multi-center, international, randomized controlled, post-market trial. The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+ System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure. Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV). Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed. Product Names: Medtronic Evolut PRO and Evolut PRO+ TAV Systems Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems
Tracking Information
- NCT #
- NCT04722250
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Howard Herrmann, MD University of Pennsylvania, United States Principal Investigator: Roxanna Mehran, MD Mount Sinai School of Medicine, United States Principal Investigator: Didier Tchétché, MD Clinique Pasteur Toulouse, France
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