Bradyarrhythmia Clinical Trial
— PACMANOfficial title:
Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)
| 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 |
| Verified date | March 2023 |
| Source | Deutsches Herzzentrum Muenchen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Deutsches Herzzentrum Muenchen |
Croatia, Germany, Japan,
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | high-sensitive Troponin T | 1 day |
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