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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01897558
Other study ID # GER-EP-012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date December 2014

Study information

Verified date March 2023
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date December 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Pacemaker implantation


Locations

Country Name City State
Croatia University Hospital Dubrava Zagreb
Germany Klinikum Kempten Kempten
Germany Krankenhaus Landshut-Achdorf Landhut
Germany Deutsches Herzzentrum München München
Japan Kenri Hospital Mishima

Sponsors (1)

Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen

Countries where clinical trial is conducted

Croatia,  Germany,  Japan, 

References & Publications (1)

Blazek P, Ferri-Certic J, Vrazic H, Lennerz C, Grebmer C, Kaitani K, Karch M, Starcevic B, Semmler V, Kolb C. Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads. Sci Rep. 2018 Mar 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary high-sensitive Troponin T 1 day
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