Early Mobilization After Pacemaker Implantation.

NCT04111354 | Completed

• 1 other identifier: Early mobilization 14-3-2019
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker Complication; Mobilization

Keywords

pacemaker; implantation; mobilization; complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of atrial lead dislodgement.

  6 months

• Incidence of ventricular lead dislodgement.

  6 months

• Incidence of hematoma (surgically treated or requiring blood transfusions.)

  6 months

• Incidence of pneumothorax.

  24 hours

• Incidence of pocket infection.

  6 months

Study Arms (2)

Short-term (4-hours) immobilization.

ACTIVE COMPARATOR

Short-term (4-hours) immobilization after primary pacemaker implantation.

Device: Pacemaker implantation

Long-term (16-24 hours) immobilization.

ACTIVE COMPARATOR

Long-term (16-24 hours) immobilization after primary pacemaker implantation.

Device: Pacemaker implantation

Interventions

Pacemaker implantation DEVICE

Pacemaker implantation

Long-term (16-24 hours) immobilization.; Short-term (4-hours) immobilization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older.
• Indication for permanent pacemaker implantation.
• Mobile and compliant patient.
• Willing and able to give written informed consent.

You may not qualify if:

• Imobile and noncompliant patient.
• Indication of CRT implantation.
• Upgrade or revision of implanted devise.
• Contraindications to pacemaker implantation.
• Gravidity.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

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

Pilsen, 32300, Czechia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: October 1, 2019
• Study Start: March 28, 2019
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)