NCT03530904

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

2.9 years

First QC Date

April 2, 2018

Last Update Submit

May 8, 2018

Conditions

Pacemaker, Artificial

Outcome Measures

Primary Outcomes (1)

  • Lead dislodgement

    incidence of device lead dislodgement

    one month

Secondary Outcomes (1)

  • Patients' comfort level

    one month

Study Arms (2)

early mobilization after cardiac device implantation

ACTIVE COMPARATOR

mobilization after 4 hours

Other: mobilization

Late mobilization after cardiac device implantation

ACTIVE COMPARATOR

Mobilization after 24 hours

Other: mobilization

Interventions

mobilizationOTHER

Early mobilization after CIED implantation

Late mobilization after cardiac device implantationearly mobilization after cardiac device implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing device implantation and are hemodynamically stable

You may not qualify if:

  • hemodincamically unstable
  • patient's request

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 2, 2018

First Posted

May 21, 2018

Study Start

June 1, 2018

Primary Completion

May 1, 2021

Study Completion

May 1, 2023

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share