Early Mobilization After Pacemaker Implantation. (EMAPI)

Charles University, Czech Republic

Status: Completed

Conditions: Pacemaker Complication; Mobilization

Treatments: Device: Pacemaker implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04111354

Early mobilization 14-3-2019

Details and patient eligibility

About

Permanent pacemaker implantation is one of the most common arrhythmological procedure. This procedure is usually accompanied by a minimum of 2-3 days hospitalization, with immobilization of patients (supine) for 16-24 hours. The optimal duration of patient´s immobilization is not determined. There is also no recommendation from individual manufacturers of pacemakers for the duration of immobilization after pacemaker implantation. The length of immobilization is based rather on the tradition established at the time of using electrodes with passive fixation. The aim of our prospective, randomized study (EMAPI) is to compare the safety of short-term (4-hours) immobilization with long-term (16-24 hours) immobilization after primary pacemaker implantation. Septal position will be used for right ventricular electrode.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years and older.
2. Indication for permanent pacemaker implantation.
3. Mobile and compliant patient.
4. Willing and able to give written informed consent.

Exclusion criteria

1. Imobile and noncompliant patient.
2. Indication of CRT implantation.
3. Upgrade or revision of implanted devise.
4. Contraindications to pacemaker implantation.
5. Gravidity.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Short-term (4-hours) immobilization.

Active Comparator group

Description:

Short-term (4-hours) immobilization after primary pacemaker implantation.

Treatment:

Device: Pacemaker implantation

Long-term (16-24 hours) immobilization.

Active Comparator group

Description:

Long-term (16-24 hours) immobilization after primary pacemaker implantation.

Treatment:

Device: Pacemaker implantation