Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-02 @ 10:39 AM
Study NCT ID:
NCT03423459
Status:
UNKNOWN
Last Update Posted:
2023-05-26
First Post:
2018-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CoreValve Evolut Pro Prospective Registry
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
Official Title:
CoreValve Evolut Pro Prospective Registry
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: