Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT03103503
Status:
TERMINATED
Last Update Posted:
2020-10-14
First Post:
2017-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Plexa ICD Lead Registry
Sponsor:
Biotronik, Inc.
Organization:
Study Overview
Official Title:
Plexa ICD Lead Registry
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Collection of long term lead performance is being transferred to an alternate data collection methodology.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: