Pacemaker ComplicationEMAPINCT04111354
Early Mobilization After Pacemaker Implantation.
A study testing Pacemaker implantation in people with Pacemaker Complication and Mobilization, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Complication, Mobilization
- What is being tested?
- Pacemaker implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 28 Mar 2019to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older.
- Indication for permanent pacemaker implantation.
- Mobile and compliant patient.
- Willing and able to give written informed consent.
Who cannot join
- Imobile and noncompliant patient.
- Indication of CRT implantation.
- Upgrade or revision of implanted devise.
- Contraindications to pacemaker implantation.
- Gravidity.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Jiri Smid, Cardiology department, University Hospital and Faculty of Medicine in Pilsen, Charles University, Czech Republic
Pilsen, 32300
About this study
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.
- Conditions
- Pacemaker Complication, Mobilization
- Being tested
- Pacemaker implantation
- Keywords
- pacemaker, implantation, mobilization, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantationDevice
Pacemaker implantation
| Study group | Role | What they receive |
|---|---|---|
| Short-term (4-hours) immobilization. | Active comparator | Short-term (4-hours) immobilization after primary pacemaker implantation. Receives: Device: Pacemaker implantation |
| Long-term (16-24 hours) immobilization. | Active comparator | Long-term (16-24 hours) immobilization after primary pacemaker implantation. Receives: Device: Pacemaker implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (6)
Incidence of atrial lead dislodgement.
comparsion of early vs. late mobilization
Measured: 6 months
Incidence of ventricular lead dislodgement.
comparsion of early vs. late mobilization
Measured: 6 months
Incidence of hematoma (surgically treated or requiring blood transfusions.)
comparsion of early vs. late mobilization
Measured: 6 months
Incidence of pneumothorax.
comparsion of early vs. late mobilization
Measured: 24 hours
Incidence of pocket infection.
comparsion of early vs. late mobilization
Measured: 6 months
Incidence of others complications.
comparsion of early vs. late mobilization, (mechanical, extracardiac complication etc.)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start28 Mar 2019
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiri Smid, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111354
- Sponsor's protocol ID
- Early mobilization 14-3-2019
- Acronym
- EMAPI
- Status last verified
- Oct 2024
- First submitted
- 6 Sep 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization After Pacemaker Implantation.
- ClinicalTrials.gov ID
- NCT04111354
- Acronym / sponsor ID
- EMAPI / Early mobilization 14-3-2019
- Conditions
- Pacemaker Complication, Mobilization
- Keywords
- pacemaker, implantation, mobilization, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term (4-hours) immobilization. | Active comparator | Device: Pacemaker implantationShort-term (4-hours) immobilization after primary pacemaker implantation. |
| Long-term (16-24 hours) immobilization. | Active comparator | Device: Pacemaker implantationLong-term (16-24 hours) immobilization after primary pacemaker implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older.
- Indication for permanent pacemaker implantation.
- Mobile and compliant patient.
- Willing and able to give written informed consent.
Key exclusion criteria (5 listed)
- Imobile and noncompliant patient.
- Indication of CRT implantation.
- Upgrade or revision of implanted devise.
- Contraindications to pacemaker implantation.
- Gravidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker implantationPacemaker implantation | Device | Long-term (16-24 hours) immobilization., Short-term (4-hours) immobilization. |
Primary outcome
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
6 secondary outcomes
Incidence of atrial lead dislodgement.
Time frame: 6 months
Incidence of ventricular lead dislodgement.
Time frame: 6 months
Incidence of hematoma (surgically treated or requiring blood transfusions.)
Time frame: 6 months
Incidence of pneumothorax.
Time frame: 24 hours
Incidence of pocket infection.
Time frame: 6 months
Incidence of others complications.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Pacemaker Complication
Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
Bradyarrhythmias, AV Block Complete
Not yet recruiting
Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
Postoperative Care After Cardiac Implantable Electronic Device Implantation
Not yet recruiting
Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
Cardiac Pacing, Permanent Pacemaker Implantation
Not yet recruitingObservational study
Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System
Pain Measurement, Chronic Pain
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implantation in people with Pacemaker Complication and Mobilization, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of incidence of adverse events from secondary outcomes depending on the length of immobilization (early vs. late). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.