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

Deutsches Herzzentrum Muenchen290 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

290

Conditions

Bradyarrhythmia

Interventions

Pacemaker implantationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

University Hospital Dubrava

Zagreb, Croatia

Klinikum Kempten

Kempten, Germany

Krankenhaus Landshut-Achdorf

Landhut, Germany

Deutsches Herzzentrum München

München, Germany

Kenri Hospital

Outcomes

Primary Outcomes

high-sensitive Troponin T

Time frame: 1 day

Data from ClinicalTrials.gov

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