Early Mobilization After Pacemaker Implantation.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pacemaker Complication
- Sponsor
- Charles University, Czech Republic
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late).
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Jiri Smid
M.D.
Charles University, Czech Republic
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late).
Time Frame: 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 Outcomes
- Incidence of hematoma (surgically treated or requiring blood transfusions.)(6 months)
- Incidence of atrial lead dislodgement.(6 months)
- Incidence of ventricular lead dislodgement.(6 months)
- Incidence of pneumothorax.(24 hours)
- Incidence of pocket infection.(6 months)
- Incidence of others complications.(6 months)