Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-29 @ 3:31 PM
Study NCT ID:
NCT02737150
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
Sponsor:
Helios Health Institute GmbH
Organization:
Study Overview
Official Title:
CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)
Status:
UNKNOWN
Status Verified Date:
2021-02
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:
SOLVE-TAVI
Brief Summary:
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: