Early Mobilization After Pacemaker Implantation.

Study Overview
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Brief Summary
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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.

Official Title
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Early Mobilization After Pacemaker Implantation.

Conditions
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Pacemaker Complication, Mobilization

Intervention / Treatment
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* Device: Pacemaker implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older. Indication for permanent pacemaker implantation. Mobile and compliant patient. Willing and able to give written informed consent. Exclusion Criteria: Imobile and noncompliant patient. Indication of CRT implantation. Upgrade or revision of implanted devise. Contraindications to pacemaker implantation. Gravidity.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short-term (4-hours) immobilization.<br>Short-term (4-hours) immobilization after primary pacemaker implantation. | Device: Pacemaker implantation<br>* Pacemaker implantation<br>|
| Active Comparator: Long-term (16-24 hours) immobilization.<br>Long-term (16-24 hours) immobilization after primary pacemaker implantation. | Device: Pacemaker implantation<br>* Pacemaker implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, implantation, mobilization, complication