Early Mobilization After Pacemaker Implantation.

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2020

Interventions

  • Device: Pacemaker implantation
    • Pacemaker implantation

Arms, Groups and Cohorts

  • Active Comparator: Short-term (4-hours) immobilization.
    • Short-term (4-hours) immobilization after primary pacemaker implantation.
  • Active Comparator: Long-term (16-24 hours) immobilization.
    • Long-term (16-24 hours) immobilization after primary pacemaker implantation.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Incidence of atrial lead dislodgement.
    • Time Frame: 6 months
    • comparsion of early vs. late mobilization
  • Incidence of ventricular lead dislodgement.
    • Time Frame: 6 months
    • comparsion of early vs. late mobilization
  • Incidence of hematoma (surgically treated or requiring blood transfusions.)
    • Time Frame: 6 months
    • comparsion of early vs. late mobilization
  • Incidence of pneumothorax.
    • Time Frame: 24 hours
    • comparsion of early vs. late mobilization
  • Incidence of pocket infection.
    • Time Frame: 6 months
    • comparsion of early vs. late mobilization
  • Incidence of others complications.
    • Time Frame: 6 months
    • comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charles University, Czech Republic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jiri Smid, M.D. – Charles University, Czech Republic

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