RecruitingNot ApplicableNCT06330675

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


Sponsor

Caporali Elena

Enrollment

558 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

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Interventions

OTHEREarly mobilization

Short-term bed-rest and immobilization

OTHERStandard of care

Bed-rest and immobility until the day-after procedure


Locations(1)

Cardiocentro Ticino Institute - EOC

Lugano, Switzerland

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NCT06330675


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