Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT04639258
Status:
TERMINATED
Last Update Posted:
2024-01-10
First Post:
2020-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Sponsor:
Medtronic Cardiovascular
Organization:
Study Overview
Official Title:
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reevaluation of clinical strategy in this patient population led to a business decision to discontinue the study. Discontinuation is not due to any patient safety, patient welfare, or quality issues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
Detailed Description:
Single-arm, descriptive, multi-center, international
All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: