Early Mobilization After Pacemaker Implantation.

Not Applicable

Completed

• Conditions: Mobilization; Pacemaker Complication
• Interventions: Device: Pacemaker implantation

• Registration Number: NCT04111354
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-28
• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short-term (4-hours) immobilization.	Pacemaker implantation	Short-term (4-hours) immobilization after primary pacemaker implantation.
Long-term (16-24 hours) immobilization.	Pacemaker implantation	Long-term (16-24 hours) immobilization after primary pacemaker implantation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of hematoma (surgically treated or requiring blood transfusions.)	6 months	comparsion of early vs. late mobilization
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 pneumothorax.	24 hours	comparsion of early vs. late mobilization
Incidence of pocket infection.	6 months	comparsion of early vs. late mobilization
Incidence of others complications.	6 months	comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.)

Trial Locations

Locations (1)

Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic; 🇨🇿 Plzen, Czechia