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NCT Number: NCT06330675

Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation

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.

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Key information

Conditions

Pacemaker Defibrillators, Implantable

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiocentro Ticino Institute - EOC

Lugano, 6900, Switzerland

Location status: Recruiting

Location contact

Elena Caporali, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Early mobilization

Other

Short-term bed-rest and immobilization

Standard of care

Other

Bed-rest and immobility until the day-after procedure

Primary outcomes

  1. Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion

    Time frame: Within 48 hours post operative

    Incidence of post-operatory complications (composite endpoint). Non inferiority margin 5%

Secondary outcomes

  1. Post-operative pain

    Time frame: 24 hours

    Pain will be assessed with the Numerical Rating Scale (NRS) scale ranging from 0 to 10 (0 corresponds to no pain and 10 to maximal level of pain).

  2. Sleep disturbance

    Time frame: The first night after surgery

    Quality of sleep will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), which ranges from 0 to 500 points, where 0 indicates the worst possible sleep quality and 500 the best possible. The sub-scores include sleep depth, sleep latency, number of awakenings, return to sleep after awakening, and overall sleep quality (each ranging from 0 to 100 points).

  3. Number of participants with postoperative urinary retention

    Time frame: Within 24 hours post operative

    Number of participants requiring an intervention such as a Foley catheter or catheterization

  4. Number of participants developing postoperative delirium

    Time frame: Within 24 hours post operative

    Number of participants who develop postoperative delirium, as assessed by the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)

  5. Number of participants developing orthostatic intolerance

    Time frame: First out-of-bed mobilization

    Number of participants who develop symptoms of orthostatic intolerance such as dizziness, nausea, vomiting, blurred vision, or syncope, during mobilization

  6. Quality of recovery

    Time frame: Day 1

    Quality of recovery assessed with the Quality of recovery-15 (QoR-15) ranging from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery), and sub-scores (physical comfort 0-50, emotional state 0-40, psychological support 0-20, physical independence 0-20 and pain 0-20).

  7. Number of participants developing pressure ulcer

    Time frame: Within 48 hours post operative

    Number of participants who develop pressure ulcers, assessed using Pressure Ulcer Classification System (stage 1, stage 2, stage 3, and stage 4)

Other outcomes

  1. Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection

    Time frame: 3 month

    Number of patients suffering with post-operatory complications

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Caporali, MD

CONTACT

[email protected]

+41 (0)91 811 53 24

Michele Villa, RN

CONTACT

[email protected]

+41 (0)91 811 50 59

Sponsors and collaborators

Lead sponsor

Caporali Elena

Other

Collaborators

  • Cardiocentro Ticino

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2024
Registry last updated
Aug 13, 2025

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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