Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
PACMAN
Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)
1 other identifier
interventional
290
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 20, 2023
March 1, 2023
1.3 years
May 2, 2013
March 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
high-sensitive Troponin T
1 day
Study Arms (2)
Ventricular pacemaker electrode
ACTIVE COMPARATORreceives an active fixation ventricular pacemaker electrode
Passive fixation ventricular pacemaker electrode
ACTIVE COMPARATORreceives a passive fixation ventricular pacemaker electrode
Interventions
Eligibility Criteria
You may qualify if:
- de-novo implantation of a pacemaker system
You may not qualify if:
- AAI pacing or cardiac resynchronization therapy
- ICD indication
- temporary pacing
- lead revision
- right ventricular pacing aimed from alternative pacing sites (other than the apex)
- lead revision
- severe tricuspid valve regurgitation
- previous myocardial infarction, coronary intervention, stroke, cardioversion or ablation in the presence of elevated troponin levels
- dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University Hospital Dubrava
Zagreb, 10000, Croatia
Klinikum Kempten
Kempten, Germany
Krankenhaus Landshut-Achdorf
Landhut, Germany
Deutsches Herzzentrum München
München, 80636, Germany
Kenri Hospital
Mishima, Japan
Related Publications (1)
Blazek P, Ferri-Certic J, Vrazic H, Lennerz C, Grebmer C, Kaitani K, Karch M, Starcevic B, Semmler V, Kolb C. Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads. Sci Rep. 2018 Mar 20;8(1):4870. doi: 10.1038/s41598-018-23209-5.
PMID: 29559697RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christof Kolb, MD
Deutsches Herzzentrum München
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2013
First Posted
July 12, 2013
Study Start
April 1, 2013
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
March 20, 2023
Record last verified: 2023-03