Comparison Between Early and Late Mobilization After Cardiac Device Implantation

• Sponsor: Carmel Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03530904
• Collaborator: (none)
• Enrollment: 400
• Arms: 2
• Anticipated Duration (Months): 59

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker, Artificial	Other: mobilization	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator
• Anticipated Study Start Date: Jun 1, 2018
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: early mobilization after cardiac device implantation mobilization after 4 hours	Other: mobilization; Early mobilization after CIED implantation
Active Comparator: Late mobilization after cardiac device implantation Mobilization after 24 hours	Other: mobilization; Early mobilization after CIED implantation

Outcome Measures

Primary Outcome Measures

1. Lead dislodgement [one month]

   incidence of device lead dislodgement

Secondary Outcome Measures

1. Patients' comfort level [one month]

   comfort level based on immobilization comfort questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All patients undergoing device implantation and are hemodynamically stable

Exclusion Criteria:

• hemodincamically unstable

• patient's request

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Carmel Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asaf Danon, Principal investigator, Carmel Medical Center
• ClinicalTrials.gov Identifier: NCT03530904
• Other Study ID Numbers: CMC-17-0015-CTIL
• First Posted: May 21, 2018
• Last Update Posted: May 21, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 21, 2018