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

March 17, 2023 updated by: Deutsches Herzzentrum Muenchen

Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Dubrava
  • Germany
      • Kempten, Germany
        • Klinikum Kempten
      • Landhut, Germany
        • Krankenhaus Landshut-Achdorf
      • München, Germany, 80636
        • Deutsches Herzzentrum München
  • Japan
      • Mishima, Japan
        • Kenri Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ventricular pacemaker electrode
receives an active fixation ventricular pacemaker electrode
Device: Pacemaker implantation
Active Comparator: Passive fixation ventricular pacemaker electrode
receives a passive fixation ventricular pacemaker electrode
Device: Pacemaker implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
high-sensitive Troponin T
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-EP-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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