Early Mobilization After Pacemaker Implantation.

Charles University, Czech Republic200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Pacemaker Complication Mobilization

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late).

Comparsion of incidence of dislodgement of atrial electrode, dislodgement of ventricular electrode in septal position, hematoma surgically treated or requiring blood transfusions, pneumothorax, pocket infection, others complications

Time frame: 6 months