Oversensing Cardiac PacemakerNCT02052453
ICD-ON Registry: Periop Management of Cardiac Devices
An observational study of Oversensing Cardiac Pacemaker and ICD, run by Edward Hospital at 3 sites in United States.
Trial summary
The purpose of this registry is to document incidence of electrical magnetic interference (EMI), change in programmed parameters or device related events in patients with Pacemakers (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring electrocautery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oversensing Cardiac Pacemaker, ICD, Surgery
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2014to Dec 2015
- How long will I take part?
- 3 Months
- 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: Patients who have a PM or ICD undergoing procedures with anticipated electrocautery.
Who may be able to join
None listed.
Who cannot join
- Have an ICD from Boston Scientific under Product Advisory related to magnet performance
- Have an ICD or PM from Biotronik or Sorin
- Surgical procedures with two or more electrocautery operators.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Elmhurst Hospital
Elmhurst, Illinois, 60126
Edward Hospital
Naperville, Illinois, 60174
About this study
Official title: ICD-ON Registry: Perioperative Management of Pacemakers and Implanted Cardioverter Defibrillators
The purpose of this registry is to document incidence of electrical magnetic interference (EMI), change in programmed parameters or device related events in patients with Pacemakers (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring electrocautery. A standardized perioperative device management protocol (ICD-ON Protocol) will be used.
Read the detailed description
Patients with PMs and ICDs have traditionally been considered at risk for electrical magnetic interference (EMI) from electrocautery. EMI can cause oversensing, pacing inhibition, or inappropriate ICD therapies. In July 2011, the Heart Rhythm Society /American Society of Anesthesiologists (HRS/ASA) published an Expert Consensus Statement on the perioperative management of PM and ICDs.
The purpose of this registry is to collect data on patients with PMs and ICDs undergoing procedures requiring electrocautery using a standardized device management protocol (ICD-ON Protocol). Decisions about management of patients with these devices will be made based on surgical location, programmed magnet response and pacemaker dependence.
This registry will document incidence of EMI, changes in programmed parameters or device related events associated with the procedures. Observational data will be collected on participants including: medical history, device parameters, surgical/cautery data, and postoperative device follow-up. For procedures not requiring reprogramming, postoperative PM and ICD interrogation will be either routine in office follow-up or remote monitoring, as per the subject's routine.
- Conditions
- Oversensing Cardiac Pacemaker, ICD, Surgery
- Keywords
- Pacemaker, ICD, Surgery, Electrocautery, Electromagnetic interference
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of EMI.
Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery.
Measured: up to 90 days
Secondary outcomes (1)
Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.
Percentage of patients with pacing inhibition recorded intraoperative or on postoperative electrograms during time of electrocautery.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oversensing Cardiac PacemakerStudies 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
- Prospective
- Enrolment
- 350 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Edward Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Abbott Medical Devices, Boston Scientific Corporation
- Responsible party
- Principal investigator, Janet Gifford, Edward-Elmhurst Health System
- Investigators
- Janet Gifford, MSN, NP, Principal investigator, Edward Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052453
- Sponsor's protocol ID
- ICDON2013
- Status last verified
- Jul 2016
- First submitted
- 30 Jan 2014
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. No abstract available.
PubMed 21722856Gifford J, Larimer K, Thomas C, May P, Stanhope S, Gami A. Randomized controlled trial of perioperative ICD management: magnet application versus reprogramming. Pacing Clin Electrophysiol. 2014 Sep;37(9):1219-24. doi: 10.1111/pace.12417. Epub 2014 May 7.
PubMed 24802626
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICD-ON Registry: Perioperative Management of Pacemakers and Implanted Cardioverter Defibrillators
- ClinicalTrials.gov ID
- NCT02052453
- Acronym / sponsor ID
- ICDON2013
- Conditions
- Oversensing Cardiac Pacemaker, ICD, Surgery
- Keywords
- Pacemaker, ICD, Surgery, Electrocautery, Electromagnetic interference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Edward HospitalUniversity, hospital or other
- Collaborators
- Medtronic, Abbott Medical Devices, Boston Scientific Corporation
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Feb 2014 (estimated)
- 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.
The purpose of this registry is to document incidence of electrical magnetic interference (EMI), change in programmed parameters or device related events in patients with Pacemakers (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring electrocautery. A standardized perioperative device management protocol (ICD-ON Protocol) will be used.
Detailed description
Patients with PMs and ICDs have traditionally been considered at risk for electrical magnetic interference (EMI) from electrocautery. EMI can cause oversensing, pacing inhibition, or inappropriate ICD therapies. In July 2011, the Heart Rhythm Society /American Society of Anesthesiologists (HRS/ASA) published an Expert Consensus Statement on the perioperative management of PM and ICDs.
The purpose of this registry is to collect data on patients with PMs and ICDs undergoing procedures requiring electrocautery using a standardized device management protocol (ICD-ON Protocol). Decisions about management of patients with these devices will be made based on surgical location, programmed magnet response and pacemaker dependence.
This registry will document incidence of EMI, changes in programmed parameters or device related events associated with the procedures. Observational data will be collected on participants including: medical history, device parameters, surgical/cautery data, and postoperative device follow-up. For procedures not requiring reprogramming, postoperative PM and ICD interrogation will be either routine in office follow-up or remote monitoring, as per the subject's routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a PM or ICD undergoing procedures with anticipated electrocautery.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Have an ICD from Boston Scientific under Product Advisory related to magnet performance
- Have an ICD or PM from Biotronik or Sorin
- Surgical procedures with two or more electrocautery operators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of EMI.
Time frame: up to 90 days
Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery.
1 secondary outcome
Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.
Time frame: up to 90 days
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 28 Jul 2017.
- Background: PubMed 21722856Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. No abstract available.
- Background: PubMed 24802626Gifford J, Larimer K, Thomas C, May P, Stanhope S, Gami A. Randomized controlled trial of perioperative ICD management: magnet application versus reprogramming. Pacing Clin Electrophysiol. 2014 Sep;37(9):1219-24. doi: 10.1111/pace.12417. Epub 2014 May 7.
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, NP principal investigator
Edward Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oversensing Cardiac Pacemaker and ICD, run by Edward Hospital at 3 sites 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 0 inclusion and 3 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 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Incidence of EMI. (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052453, which also lists 2 linked publications.
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 28 Jul 2017.