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Early Mobilization After Pacemaker Implantation. (EMAPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111354
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jiri Smid, Charles University, Czech Republic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pacemaker Complication Mobilization Device: Pacemaker implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Mobilization After Pacemaker Implantation.
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Active Comparator: Short-term (4-hours) immobilization.
Short-term (4-hours) immobilization after primary pacemaker implantation.
Device: Pacemaker implantation
Pacemaker implantation

Active Comparator: Long-term (16-24 hours) immobilization.
Long-term (16-24 hours) immobilization after primary pacemaker implantation.
Device: Pacemaker implantation
Pacemaker implantation




Primary Outcome Measures :
  1. Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late). [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Incidence of atrial lead dislodgement. [ Time Frame: 6 months ]
    comparsion of early vs. late mobilization

  2. Incidence of ventricular lead dislodgement. [ Time Frame: 6 months ]
    comparsion of early vs. late mobilization

  3. Incidence of hematoma (surgically treated or requiring blood transfusions.) [ Time Frame: 6 months ]
    comparsion of early vs. late mobilization

  4. Incidence of pneumothorax. [ Time Frame: 24 hours ]
    comparsion of early vs. late mobilization

  5. Incidence of pocket infection. [ Time Frame: 6 months ]
    comparsion of early vs. late mobilization

  6. Incidence of others complications. [ Time Frame: 6 months ]
    comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111354


Locations
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Czechia
Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic Recruiting
Plzen, Czechia, 32300
Contact: Jiri Smid    +420377103170    smidj@fnplzen.cz   
Sponsors and Collaborators
Charles University, Czech Republic
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Responsible Party: Jiri Smid, M.D., Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT04111354    
Other Study ID Numbers: Early mobilization 14-3-2019
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiri Smid, Charles University, Czech Republic:
pacemaker
implantation
mobilization
complication