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Comparison Between Early and Late Mobilization After Cardiac Device Implantation

Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03530904
Enrollment
400
Registered
2018-05-21
Start date
2018-06-01
Completion date
2023-05-01
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacemaker, Artificial

Brief summary

Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvenience to the patients.

Detailed description

Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvinience to the patients. Patients will be randomally assigned to early mobilization (after 4 hours) or bed restriction till the morning after the procedure. Primary outcome: lead malfunction, patients' satisfaction

Interventions

OTHERmobilization

Early mobilization after CIED implantation

Sponsors

Carmel Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients undergoing device implantation and are hemodynamically stable

Exclusion criteria

* hemodincamically unstable * patient's request

Design outcomes

Primary

MeasureTime frameDescription
Lead dislodgementone monthincidence of device lead dislodgement

Secondary

MeasureTime frameDescription
Patients' comfort levelone monthcomfort level based on immobilization comfort questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026