Mobilization, Pacemaker Complication
Conditions
Keywords
pacemaker, implantation, mobilization, complication
Brief summary
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.
Interventions
DEVICEPacemaker implantation
Pacemaker implantation
Sponsors
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years and older. 2. Indication for permanent pacemaker implantation. 3. Mobile and compliant patient. 4. Willing and able to give written informed consent.
Exclusion criteria
1. Imobile and noncompliant patient. 2. Indication of CRT implantation. 3. Upgrade or revision of implanted devise. 4. Contraindications to pacemaker implantation. 5. Gravidity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late). | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hematoma (surgically treated or requiring blood transfusions.) | 6 months | comparsion of early vs. late mobilization |
| Incidence of pneumothorax. | 24 hours | comparsion of early vs. late mobilization |
| Incidence of others complications. | 6 months | comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.) |
| Incidence of atrial lead dislodgement. | 6 months | comparsion of early vs. late mobilization |
| Incidence of ventricular lead dislodgement. | 6 months | comparsion of early vs. late mobilization |
| Incidence of pocket infection. | 6 months | comparsion of early vs. late mobilization |
Countries
Czechia
Outcome results
None listed