Electromagnetic InterferenceNCT03508128
Evaluation of EMI in Patients With Micra Leadless Pacemaker
An observational study of Electromagnetic Interference, run by Edward-Elmhurst Health System at 1 site in United States.
Trial summary
Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electromagnetic Interference
- What is being tested?
- surgical procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 18 Aug 2018
- Phase
- Observational
- 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
Study population: Subjects with Micra leadless pacemakers implanted at Edward-Elmhurst Healthcare since May 2016 who then required a surgical procedure.
Who may be able to join
- subjects with an implanted Micra pacemaker who required a surgical procedure
Who cannot join
- no Micra pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
EdwardElmhurst Healthcare
Naperville, Illinois, 60174
About this study
Official title: Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker
Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).
Read the detailed description
Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers.
Subjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.
- Conditions
- Electromagnetic Interference
- Being tested
- surgical procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical procedureOther
Surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Micra subjects | Surgical procedure Receives: Other: surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMI
Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms
Measured: up to 6 months next postop interrogation
Secondary outcomes (1)
Device reset
Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms
Measured: up to 6 months next postop interrogation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start4 Apr 2018
- Primary completion18 Aug 2018
- Study completion18 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electromagnetic InterferenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward-Elmhurst Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Gifford, Edward-Elmhurst Health System
- Investigators
- Janet Gifford, MSN, Principal investigator, Edward-Elmhurst Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508128
- Sponsor's protocol ID
- EdwardH
- Status last verified
- Aug 2018
- First submitted
- 5 Apr 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker
- ClinicalTrials.gov ID
- NCT03508128
- Acronym / sponsor ID
- EdwardH
- Conditions
- Electromagnetic Interference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Edward-Elmhurst Health SystemUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 18 Aug 2018 (actual)
- Study completion
- 18 Aug 2018 (actual)
- First posted
- 25 Apr 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.
Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).
Detailed description
Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers.
Subjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micra subjects | – | Other: surgical procedureSurgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Micra leadless pacemakers implanted at Edward-Elmhurst Healthcare since May 2016 who then required a surgical procedure.
Key inclusion criteria (1 listed)
- subjects with an implanted Micra pacemaker who required a surgical procedure
Key exclusion criteria (1 listed)
- no Micra pacemaker
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 |
|---|---|---|
| surgical procedureSurgical procedure | Other | Micra subjects |
Primary outcome
EMI
Time frame: up to 6 months next postop interrogation
Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms
1 secondary outcome
Device reset
Time frame: up to 6 months next postop interrogation
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 21 Aug 2018.
- Individual participant dataSharing planned: Undecided
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.
Janet Gifford, MSN principal investigator
Edward-Elmhurst Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electromagnetic Interference, run by Edward-Elmhurst Health System at 1 site in United States.
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 1 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 21 Aug 2018. 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 United States. 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?
EMI (time frame: up to 6 months next postop interrogation). 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 Aug 2018.