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Permanent pacemaker implantation is one of the most common arrhythmological procedure. This procedure is usually accompanied by a minimum of 2-3 days hospitalization, with immobilization of patients (supine) for 16-24 hours. The optimal duration of patient´s immobilization is not determined. There is also no recommendation from individual manufacturers of pacemakers for the duration of immobilization after pacemaker implantation. The length of immobilization is based rather on the tradition established at the time of using electrodes with passive fixation. The aim of our prospective, randomized study (EMAPI) is to compare the safety of short-term (4-hours) immobilization with long-term (16-24 hours) immobilization after primary pacemaker implantation. Septal position will be used for right ventricular electrode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term (4-hours) immobilization. | Active Comparator | Short-term (4-hours) immobilization after primary pacemaker implantation. |
|
| Long-term (16-24 hours) immobilization. | Active Comparator | Long-term (16-24 hours) immobilization after primary pacemaker implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker implantation | Device | Pacemaker implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late). | Comparsion of incidence of dislodgement of atrial electrode, dislodgement of ventricular electrode in septal position, hematoma surgically treated or requiring blood transfusions, pneumothorax, pocket infection, others complications | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of atrial lead dislodgement. | comparsion of early vs. late mobilization | 6 months |
| Incidence of ventricular lead dislodgement. | comparsion of early vs. late mobilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic | Pilsen | 32300 | Czechia |
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| 6 months |
| Incidence of hematoma (surgically treated or requiring blood transfusions.) | comparsion of early vs. late mobilization | 6 months |
| Incidence of pneumothorax. | comparsion of early vs. late mobilization | 24 hours |
| Incidence of pocket infection. | comparsion of early vs. late mobilization | 6 months |
| Incidence of others complications. | comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.) | 6 months |