Pacemaker, ArtificialNCT03530904
Comparison Between Early and Late Mobilization After Cardiac Device Implantation
A study testing mobilization in people with Pacemaker, Artificial, run by Carmel Medical Center.
Trial summary
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Artificial
- What is being tested?
- mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 1 May 2023
- 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
- All patients undergoing device implantation and are hemodynamically stable
Who cannot join
- hemodincamically unstable
- patient's request
About this study
Official title: Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvenience to the patients.
Read the detailed description
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvinience to the patients.
Patients will be randomally assigned to early mobilization (after 4 hours) or bed restriction till the morning after the procedure.
Primary outcome: lead malfunction, patients' satisfaction
- Conditions
- Pacemaker, Artificial
- Being tested
- mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilizationOther
Early mobilization after CIED implantation
| Study group | Role | What they receive |
|---|---|---|
| early mobilization after cardiac device implantation | Active comparator | mobilization after 4 hours Receives: Other: mobilization |
| Late mobilization after cardiac device implantation | Active comparator | Mobilization after 24 hours Receives: Other: mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead dislodgement
incidence of device lead dislodgement
Measured: one month
Secondary outcomes (1)
Patients' comfort level
comfort level based on immobilization comfort questionnaire
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker, ArtificialStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asaf Danon, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530904
- Sponsor's protocol ID
- CMC-17-0015-CTIL
- Status last verified
- May 2018
- First submitted
- 2 Apr 2018
- Last updated
- 21 May 2018
- 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 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator
- ClinicalTrials.gov ID
- NCT03530904
- Acronym / sponsor ID
- CMC-17-0015-CTIL
- Conditions
- Pacemaker, Artificial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 21 May 2018 (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.
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvenience to the patients.
Detailed description
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvinience to the patients.
Patients will be randomally assigned to early mobilization (after 4 hours) or bed restriction till the morning after the procedure.
Primary outcome: lead malfunction, patients' satisfaction
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early mobilization after cardiac device implantation | Active comparator | Other: mobilizationmobilization after 4 hours |
| Late mobilization after cardiac device implantation | Active comparator | Other: mobilizationMobilization after 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing device implantation and are hemodynamically stable
Key exclusion criteria (2 listed)
- hemodincamically unstable
- patient's request
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 |
|---|---|---|
| mobilizationEarly mobilization after CIED implantation | Other | Late mobilization after cardiac device implantation, early mobilization after cardiac device implantation |
Primary outcome
Lead dislodgement
Time frame: one month
incidence of device lead dislodgement
1 secondary outcome
Patients' comfort level
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing mobilization in people with Pacemaker, Artificial, run by Carmel Medical Center.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Lead dislodgement (time frame: one month). 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 21 May 2018.