Comparison Between Early and Late Mobilization After Cardiac Device Implantation

Pacemaker, Artificial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03530904
• Other study ID #: CMC-17-0015-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2018
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients undergoing device implantation and are hemodynamically stable

Exclusion Criteria:

• hemodincamically unstable

• patient's request

Related Conditions & MeSH terms

• Pacemaker, Artificial

Intervention

Other:
• mobilization
Early mobilization after CIED implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead dislodgement	incidence of device lead dislodgement	one month
Secondary	Patients' comfort level	comfort level based on immobilization comfort questionnaire	one month