An interventional study of Pacemaker implantation in Pacemaker Complication and Mobilization, sponsored by Charles University, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Charles University, Czech Republic · Not applicable, Interventional, and Prevention
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.
Charles University, Czech Republic is the lead sponsor of 227 studies on the registry; 75 are open to participants now.
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Exclusion Criteria:
Short-term (4-hours) immobilization after primary pacemaker implantation.
Device: Pacemaker implantation
Long-term (16-24 hours) immobilization after primary pacemaker implantation.
Device: Pacemaker implantation
Pacemaker implantation
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
Time frame: 6 months
Incidence of atrial lead dislodgement.
comparsion of early vs. late mobilization
Time frame: 6 months
Incidence of ventricular lead dislodgement.
comparsion of early vs. late mobilization
Time frame: 6 months
Incidence of hematoma (surgically treated or requiring blood transfusions.)
comparsion of early vs. late mobilization
Time frame: 6 months
Incidence of pneumothorax.
comparsion of early vs. late mobilization
Time frame: 24 hours
Incidence of pocket infection.
comparsion of early vs. late mobilization
Time frame: 6 months
Incidence of others complications.
comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.)
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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