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Completed

NCT Number: NCT04111354

Early Mobilization After Pacemaker Implantation.

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.

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Key information

Conditions

Pacemaker Complication Mobilization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pilsen, 32300, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Gravidity.

Treatment and study plan

Pacemaker implantation

Device

Pacemaker implantation

Primary outcomes

  1. 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

  1. Incidence of atrial lead dislodgement.

    Time frame: 6 months

    comparsion of early vs. late mobilization

  2. Incidence of ventricular lead dislodgement.

    Time frame: 6 months

    comparsion of early vs. late mobilization

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

    Time frame: 6 months

    comparsion of early vs. late mobilization

  4. Incidence of pneumothorax.

    Time frame: 24 hours

    comparsion of early vs. late mobilization

  5. Incidence of pocket infection.

    Time frame: 6 months

    comparsion of early vs. late mobilization

  6. Incidence of others complications.

    Time frame: 6 months

    comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.)

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Acronym: EMAPI

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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