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Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes (PACMAN)

Primary Purpose

Bradyarrhythmia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pacemaker implantation
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradyarrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • de-novo implantation of a pacemaker system

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital Dubrava
  • Klinikum Kempten
  • Krankenhaus Landshut-Achdorf
  • Deutsches Herzzentrum München
  • Kenri Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ventricular pacemaker electrode

Passive fixation ventricular pacemaker electrode

Arm Description

receives an active fixation ventricular pacemaker electrode

receives a passive fixation ventricular pacemaker electrode

Outcomes

Primary Outcome Measures

high-sensitive Troponin T

Secondary Outcome Measures

Full Information

First Posted
May 2, 2013
Last Updated
March 17, 2023
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT01897558
Brief Title
Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
Acronym
PACMAN
Official Title
Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradyarrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ventricular pacemaker electrode
Arm Type
Active Comparator
Arm Description
receives an active fixation ventricular pacemaker electrode
Arm Title
Passive fixation ventricular pacemaker electrode
Arm Type
Active Comparator
Arm Description
receives a passive fixation ventricular pacemaker electrode
Intervention Type
Device
Intervention Name(s)
Pacemaker implantation
Primary Outcome Measure Information:
Title
high-sensitive Troponin T
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: de-novo implantation of a pacemaker system Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christof Kolb, MD
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinikum Kempten
City
Kempten
Country
Germany
Facility Name
Krankenhaus Landshut-Achdorf
City
Landhut
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
München
ZIP/Postal Code
80636
Country
Germany
Facility Name
Kenri Hospital
City
Mishima
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29559697
Citation
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.
Results Reference
result

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Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes

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