Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT03530904
Status:
UNKNOWN
Last Update Posted:
2018-05-21
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Early and Late Mobilization After Cardiac Device Implantation
Sponsor:
Carmel Medical Center
Organization:
Study Overview
Official Title:
Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: