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

Not Applicable

Completed

• Conditions: Bradyarrhythmia
• Interventions: Device: Pacemaker implantation

• Registration Number: NCT01897558
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-12
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ventricular pacemaker electrode	Pacemaker implantation	receives an active fixation ventricular pacemaker electrode
Passive fixation ventricular pacemaker electrode	Pacemaker implantation	receives a passive fixation ventricular pacemaker electrode

Primary Outcome Measures

Name	Time	Method
high-sensitive Troponin T	1 day

Trial Locations

Locations (5)

Krankenhaus Landshut-Achdorf; 🇩🇪 Landhut, Germany

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia

Klinikum Kempten; 🇩🇪 Kempten, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany

Kenri Hospital; 🇯🇵 Mishima, Japan