Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
Not Applicable
Completed
- Conditions
- Bradyarrhythmia
- 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
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
- Primary Outcome Measures
Name Time Method high-sensitive Troponin T 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
University Hospital Dubrava
🇭🇷Zagreb, Croatia
Klinikum Kempten
🇩🇪Kempten, Germany
Krankenhaus Landshut-Achdorf
🇩🇪Landhut, Germany
Deutsches Herzzentrum München
🇩🇪München, Germany
Kenri Hospital
🇯🇵Mishima, Japan
University Hospital Dubrava🇭🇷Zagreb, Croatia