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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Elena Caporali, MD; Michele Villa, RN

Data sourced from clinicaltrials.gov

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