Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT

Caporali Elena

Status: Enrolling

Conditions: Defibrillators, Implantable; Pacemaker

Treatments: Other: Early mobilization; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT06330675

2022-01820

Details and patient eligibility

About

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.

Enrollment: 558 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

Mobilization 4-h after procedure

Experimental group

Description:

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

Treatment:

Other: Early mobilization

Mobilization day-after procedure

Active Comparator group

Description:

Standard of care with prolungate bed-rest after CIED implantation

Treatment:

Other: Standard of care