Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-26 @ 3:39 PM
Study NCT ID:
NCT01897558
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Study Overview
Official Title:
Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)
Status:
COMPLETED
Status Verified Date:
2023-03
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:
PACMAN
Brief Summary:
Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. Both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. The PACMAN-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.
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?: