Early Mobilization After Pacemaker Implantation. (EMAPI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pacemaker Complication; Mobilization
• Intervention / Treatment: Device: Pacemaker implantation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Plzen, Czechia, 32300
    • Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pacemaker; implantation; complication; mobilization
• Other Study ID Numbers: Early mobilization 14-3-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No