Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-04-13 @ 9:33 PM
Study NCT ID:
NCT02506569
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2015-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ProMRI 3T ENHANCED Master Study
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
ProMRI 3T ENHANCED Master Study
Status:
COMPLETED
Status Verified Date:
2018-02
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:
None
Brief Summary:
The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions .
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: