EMAPI: Early Mobilization After Pacemaker Implantation.

• Sponsor: Charles University, Czech Republic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04111354
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42.2
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 28, 2019
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

   comparsion of early vs. late mobilization

2. Incidence of ventricular lead dislodgement. [6 months]

   comparsion of early vs. late mobilization

3. Incidence of hematoma (surgically treated or requiring blood transfusions.) [6 months]

   comparsion of early vs. late mobilization

4. Incidence of pneumothorax. [24 hours]

   comparsion of early vs. late mobilization

5. Incidence of pocket infection. [6 months]

   comparsion of early vs. late mobilization

6. Incidence of others complications. [6 months]

   comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic	Plzen		Czechia	32300

Sponsors and Collaborators

• Charles University, Czech Republic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 1, 2019
• Last Update Posted: Aug 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiri Smid, M.D., Charles University, Czech Republic: pacemaker; implantation; mobilization; complication

Study Results

No Results Posted as of Aug 5, 2021