Early Mobilization After Pacemaker Implantation.

NCT ID: NCT04111354

Last Updated: 2024-10-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pacemaker Complication Mobilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Short-term (4-hours) immobilization.

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

Group Type ACTIVE_COMPARATOR

Pacemaker implantation

Intervention Type DEVICE

Pacemaker implantation

Long-term (16-24 hours) immobilization.

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

Group Type ACTIVE_COMPARATOR

Pacemaker implantation

Intervention Type DEVICE

Pacemaker implantation

Interventions

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Pacemaker implantation

Pacemaker implantation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Jiri Smid

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic

Pilsen, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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Early mobilization 14-3-2019

Identifier Type: -

Identifier Source: org_study_id

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