Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation

NCT06330675 | Recruiting

• 1 other identifier: 2022-01820
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

Brief 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 mobilization at 4-h against day-after procedure.

Conditions

Pacemaker; Defibrillators, Implantable

Keywords

Pacemaker; Implantable cardioverter-defibrillator; Early mobilization; Bed-rest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Post-operative pain

  24 hours

• Sleep disturbance

  The first night after surgery

• Number of participants with postoperative urinary retention

  Within 24 hours post operative

• Number of participants developing postoperative delirium

  Within 24 hours post operative

• Number of participants developing orthostatic intolerance

  First out-of-bed mobilization

Other Outcomes (1)

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

  3 month

Study Arms (2)

Mobilization 4-h after procedure

EXPERIMENTAL

Short-term bed-rest (4-h) after CIED implantation

Other: Early mobilization

Mobilization day-after procedure

ACTIVE COMPARATOR

Standard of care with prolungate bed-rest after CIED implantation

Other: Standard of care

Interventions

Early mobilization OTHER

Short-term bed-rest and immobilization

Mobilization 4-h after procedure

Standard of care OTHER

Bed-rest and immobility until the day-after procedure

Mobilization day-after procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Caporali Elena: lead
• Cardiocentro Ticino: collaborator

Study Sites (1)

Cardiocentro Ticino Institute - EOC

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Interventions

Early Ambulation; Standard of Care

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elena Caporali, MD

  Cardiocentro Ticino Institute - EOC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Caporali, MD

CONTACT

+41 (0)91 811 53 24; elena.caporali@eoc.ch

Michele Villa, RN

CONTACT

+41 (0)91 811 50 59; michele.villa@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: February 1, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)