NCT03423459

CoreValve Evolut Pro Prospective Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	TAVR	Transcatheter Aortic Valve Replacement

Timeline

• Start date: 2018-01-18
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2018-02-06
• Last updated: 2023-05-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study