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OpenTrials
Completed

NCT Number: NCT01897558

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

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.

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Key information

Conditions

Bradyarrhythmia Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dubrava, Zagreb, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacemaker implantation

Device

Primary outcomes

  1. high-sensitive Troponin T

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study title

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

Acronym: PACMAN

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2013
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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