CoreValve Evolut Pro Prospective Registry
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Stenosis
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to...
The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak. In this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice.
Tracking Information
- NCT #
- NCT03423459
- Collaborators
- Medtronic Cardiovascular
- Investigators
- Not Provided
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