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

German Heart Center Munich

Status: Completed

Conditions: Bradyarrhythmia

Treatments: Device: Pacemaker implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01897558

GER-EP-012

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups

Ventricular pacemaker electrode

Active Comparator group

Description:

receives an active fixation ventricular pacemaker electrode

Treatment:

Device: Pacemaker implantation

Passive fixation ventricular pacemaker electrode

Active Comparator group

Description:

receives a passive fixation ventricular pacemaker electrode

Treatment:

Device: Pacemaker implantation