PacemakerNCT06330675
Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation
A study testing Early mobilization in people with Pacemaker and Defibrillators, Implantable, run by Caporali Elena at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Defibrillators, Implantable
- What is being tested?
- Early mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2023to 14 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Signed informed consent form
- New permanent pacemaker implantation (PM) or implantable cardioverter-defibrillator (ICD)
Who cannot join
- CIED implants after recent cardiac surgery
- Upgrade or revision of implanted device
- CRT implantation
- Intraoperative complications
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pacemaker, Defibrillators, Implantable
- Being tested
- Early mobilization, Standard of care
- Keywords
- Pacemaker, Implantable cardioverter-defibrillator, Early mobilization, Bed-rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilizationOther
Short-term bed-rest and immobilization
Standard of careOther
Bed-rest and immobility until the day-after procedure
| Study group | Role | What they receive |
|---|---|---|
| Mobilization 4-h after procedure | Experimental | Short-term bed-rest (4-h) after CIED implantation Receives: Other: Early mobilization |
| Mobilization day-after procedure | Active comparator | Standard of care with prolungate bed-rest after CIED implantation Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion
Incidence of post-operatory complications (composite endpoint). Non inferiority margin 5%
Measured: Within 48 hours post operative
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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
Measured: Within 24 hours post operative
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).
Measured: 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)
Measured: Within 48 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Feb 2023
- Primary completion14 Aug 2025
- Study completion14 Nov 2025
Why it stopped: Terminated due to lower-than-expected enrollment. No safety concerns contributed to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caporali Elena
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiocentro Ticino
- Responsible party
- Sponsor-investigator, Caporali Elena, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Elena Caporali, MD, Principal investigator, Cardiocentro Ticino Institute - EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330675
- Sponsor's protocol ID
- 2022-01820
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No