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Recruiting NCT06330675

Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation

No phase Interventional Pacemaker Defibrillators, Implantable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early mobilization, Standard of care.
Who it may be relevant to
Registry conditions: Pacemaker, Defibrillators, Implantable. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Benefits of Mobilization at 4 Hours Compared to 24 Hours After Implantation of an Intracardiac Electronic Device: a Randomized Clinical Trial of Non-inferiority, Open and Controlled in Parallel Groups

Overview

Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure.

Interventions

  • Other Early mobilization
    Short-term bed-rest and immobilization
  • Other Standard of care
    Bed-rest and immobility until the day-after procedure

Primary outcome measures

  • Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion [Time frame: Within 48 hours post operative]
Secondary outcome measures (7)
  • Post-operative pain [Time frame: 24 hours]
  • Sleep disturbance [Time frame: The first night after surgery]
  • Number of participants with postoperative urinary retention [Time frame: Within 24 hours post operative]
  • Number of participants developing postoperative delirium [Time frame: Within 24 hours post operative]
  • Number of participants developing orthostatic intolerance [Time frame: First out-of-bed mobilization]
  • Quality of recovery [Time frame: Day 1]
  • Number of participants developing pressure ulcer [Time frame: Within 48 hours post operative]

Eligibility criteria

Inclusion criteria

  • ≥ 18 years old
  • Signed informed consent form
  • New permanent pacemaker implantation (PM) or implantable cardioverter-defibrillator (ICD)

Exclusion criteria

  • CIED implants after recent cardiac surgery
  • Upgrade or revision of implanted device
  • CRT implantation
  • Intraoperative complications

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Cardiocentro Ticino Institute - EOC — Lugano

Identifiers

NCT: NCT06330675 · 2022-01820

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗