CoreValve Evolut Pro Prospective Registry

Status Active, not recruiting

Clinical Trial Summary

The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03423459
Study type	Observational [Patient Registry]
Source	Medstar Health Research Institute
Contact
Status	Active, not recruiting
Phase
Start date	January 18, 2018
Completion date	December 31, 2024

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See also
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