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

NCT01897558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2023-03-20

No results posted yet for this study

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.

Conditions

  • Bradyarrhythmia

Interventions

DEVICE

Pacemaker implantation

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Christof Kolb, MD · Deutsches Herzzentrum München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • Croatia
  • Germany
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01897558 on ClinicalTrials.gov