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Comparison Between Early and Late Mobilization After Cardiac Device Implantation

NCT ID: NCT03530904

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2023-05-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pacemaker, Artificial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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early mobilization after cardiac device implantation

mobilization after 4 hours

Group Type ACTIVE_COMPARATOR

mobilization

Intervention Type OTHER

Early mobilization after CIED implantation

Late mobilization after cardiac device implantation

Mobilization after 24 hours

Group Type ACTIVE_COMPARATOR

mobilization

Intervention Type OTHER

Early mobilization after CIED implantation

Interventions

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mobilization

Early mobilization after CIED implantation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

All patients undergoing device implantation and are hemodynamically stable

Exclusion Criteria

* hemodincamically unstable
* patient's request
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Asaf Danon

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CMC-17-0015-CTIL

Identifier Type: -

Identifier Source: org_study_id

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