Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336284
Status:
COMPLETED
Last Update Posted:
2010-08-03
First Post:
2006-06-09
Brief Title:
TRUST Lumos-T Safely RedUceS RouTine Office Device Follow-up
Sponsor:
Biotronik Inc
Organization:
Biotronik Inc
Study Overview
Official Title:
TRUST Lumos-T Safely RedUceS RouTine Office Device Follow-up
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
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:
TRUST
Brief Summary:
This study is a multi-center prospective and randomized trial The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system HM can safely reduce the number of regularly scheduled office follow-up visits compared to the conventional method of implantable cardioverter defibrillator ICD follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None