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

Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01897558

Acronym

PACMAN

Enrollment

290

Registered

2013-07-12

Start date

2013-04-30

Completion date

2014-12-31

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradyarrhythmia

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.

Interventions

DEVICEPacemaker implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
high-sensitive Troponin T	1 day

Countries

Croatia, Germany, Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026