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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Bradyarrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ventricular pacemaker electrode

receives an active fixation ventricular pacemaker electrode

Group Type ACTIVE_COMPARATOR

Pacemaker implantation

Intervention Type DEVICE

Passive fixation ventricular pacemaker electrode

receives a passive fixation ventricular pacemaker electrode

Group Type ACTIVE_COMPARATOR

Pacemaker implantation

Intervention Type DEVICE

Interventions

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Pacemaker implantation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No