Early Mobilization After Pacemaker Implantation.

Pacemaker Complication Clinical Trial

— EMAPI  

Official title:

Early Mobilization After Pacemaker Implantation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04111354
• Other study ID #: Early mobilization 14-3-2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mobilization
• Pacemaker Complication

Intervention

Device:
• Pacemaker implantation
Pacemaker implantation

Locations

Country	Name	City	State
Czechia	Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic	Plzen

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of atrial lead dislodgement.	comparsion of early vs. late mobilization	6 months
Secondary	Incidence of ventricular lead dislodgement.	comparsion of early vs. late mobilization	6 months
Secondary	Incidence of hematoma (surgically treated or requiring blood transfusions.)	comparsion of early vs. late mobilization	6 months
Secondary	Incidence of pneumothorax.	comparsion of early vs. late mobilization	24 hours
Secondary	Incidence of pocket infection.	comparsion of early vs. late mobilization	6 months
Secondary	Incidence of others complications.	comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.)	6 months