Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-02 @ 8:56 AM
Study NCT ID:
NCT01454050
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2011-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumax 740 Master Study
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
PME/Master Study of the Lumax 740 ICD Family
Status:
COMPLETED
Status Verified Date:
2012-11
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:
Lumax 740
Brief Summary:
The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.
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?: