Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-04-19 @ 3:37 PM
Study NCT ID:
NCT02202434
Status:
TERMINATED
Last Update Posted:
2021-12-17
First Post:
2014-07-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
RCT/Roll-in completed. CAS/21mm/Nested Registry terminated (investigational device is no longer available)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPRISE III
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.
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?: