Comparison Between Early and Late Mobilization After Cardiac Device Implantation

Israel Healthcare Foundation

Status: Unknown

Conditions: Pacemaker, Artificial

Treatments: Other: mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT03530904

CMC-17-0015-CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients undergoing device implantation and are hemodynamically stable

Exclusion criteria

• hemodincamically unstable
• patient's request

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

early mobilization after cardiac device implantation

Active Comparator group

Description:

mobilization after 4 hours

Treatment:

Other: mobilization

Late mobilization after cardiac device implantation

Active Comparator group

Description:

Mobilization after 24 hours

Treatment:

Other: mobilization