Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Defibrillators, Implantable; Pacemaker
• Intervention / Treatment: Other: Early mobilization; Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 558
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Caporali, MD; Phone Number: +41 (0)91 811 53 24; Email: elena.caporali@eoc.ch
• Study Contact Backup: Name: Michele Villa, RN; Phone Number: +41 (0)91 811 50 59; Email: michele.villa@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • Cardiocentro Ticino Institute - EOC
    • Contact: Elena Caporali, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobilization 4-h after procedure; Short-term bed-rest (4-h) after CIED implantation	Other: Early mobilization; Short-term bed-rest and immobilization
Active Comparator: Mobilization day-after procedure; Standard of care with prolungate bed-rest after CIED implantation	Other: Standard of care; Bed-rest and immobility until the day-after procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion	Incidence of post-operatory complications (composite endpoint). Non inferiority margin 5%	Within 48 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	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).	24 hours
Sleep disturbance	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).	The first night after surgery
Number of participants with postoperative urinary retention	Number of participants requiring an intervention such as a Foley catheter or catheterization	Within 24 hours post operative
Number of participants developing postoperative delirium	Number of participants who develop postoperative delirium, as assessed by the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)	Within 24 hours post operative
Number of participants developing orthostatic intolerance	Number of participants who develop symptoms of orthostatic intolerance such as dizziness, nausea, vomiting, blurred vision, or syncope, during mobilization	First out-of-bed mobilization
Quality of recovery	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).	Day 1
Number of participants developing pressure ulcer	Number of participants who develop pressure ulcers, assessed using Pressure Ulcer Classification System (stage 1, stage 2, stage 3, and stage 4)	Within 48 hours post operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection	Number of patients suffering with post-operatory complications	3 month

Collaborators and Investigators

• Sponsor: Caporali Elena
• Collaborators: Cardiocentro Ticino
• Investigators: Principal Investigator: Elena Caporali, MD, Cardiocentro Ticino Institute - EOC

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pacemaker; Early mobilization; Implantable cardioverter-defibrillator; Bed-rest
• Other Study ID Numbers: 2022-01820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No