Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-01-29 @ 3:59 PM
Study NCT ID:
NCT02096692
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2014-03-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ProMRI Study of the Iforia ICD System (Phase C)
Sponsor:
Biotronik, Inc.
Organization:
Study Overview
Official Title:
ProMRI Study of the Iforia ICD System (Phase C)
Status:
COMPLETED
Status Verified Date:
2016-02
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 objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
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?: