Implantable Cardioverter-DefibrillatorsDinosurNCT00806377
Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures
An observational study of Implantable Cardioverter-Defibrillators, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
The purpose of this study is: To document the incidence of electromagnetic oversensing of ICDs during non-thoracic surgery. To identify any non-thoracic procedure with a higher incidence of generating electromagnetic oversensing. To document the ability of dual chamber ICDs to discriminate electromagnetic oversensing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Cardioverter-Defibrillators
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2011
- 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 undergoing elective, non-thoracic surgical procedures will be enrolled.
Who may be able to join
- Patients with Medtronic or Boston Scientific single and dual chamber ICDs
Who cannot join
- Non-thoracic ICD generator placement (abdominal)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
The purpose of this study is:
- To document the incidence of electromagnetic oversensing of ICDs during non-thoracic surgery.
- To identify any non-thoracic procedure with a higher incidence of generating electromagnetic oversensing.
- To document the ability of dual chamber ICDs to discriminate electromagnetic oversensing.
Read the detailed description
Electrocautery devices used during surgery generate a high electromagnetic field with a frequency that may result in ICD oversensing. Oversensing may in turn result in false detection of a ventricular arrhythmia and for the ICD to discharge. Because of this possibility, patients frequently have their ICDs inactivated prior to the procedure.
Although oversensing appears to be highly unlikely in clinical practice, vast resources are utilized in the process of deactivating and reactivating ICDs for surgeries. In addition, there are reports of deaths from failure to reactivate ICDs following elective surgery.
In this study we intend to document the incidence of oversensing, identify procedures with a higher likelihood of oversensing and evaluate the ability of dual chamber ICDs to discriminate electromagnetic oversensing.
- Conditions
- Implantable Cardioverter-Defibrillators
- Keywords
- Electromagnetic field, Oversensing, Non-thoracic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromagnetic oversensing will be reported as a percentage of the total enrolled patients
Measured: Assessed at time of procedure
Secondary outcomes (2)
Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing
Measured: Assessed at time of procedure
Incidence of dual chamber ICDs discriminating electromagnetic oversensing.
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2011
- Study completionOct 2011
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 Implantable Cardioverter-DefibrillatorsStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William T Katsyiannis, MD, Principal investigator, Minneapolis Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806377
- Sponsor's protocol ID
- EP001
- Acronym
- Dinosur
- Status last verified
- May 2017
- First submitted
- 9 Dec 2008
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fiek M, Dorwarth U, Durchlaub I, Janko S, Von Bary C, Steinbeck G, Hoffmann E. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs? Pacing Clin Electrophysiol. 2004 Mar;27(3):293-8. doi: 10.1111/j.1540-8159.2004.00430.x.
PubMed 15009852Hauser RG, Kallinen L. Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database. Heart Rhythm. 2004 Oct;1(4):399-405. doi: 10.1016/j.hrthm.2004.05.006.
PubMed 15851191
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures
- ClinicalTrials.gov ID
- NCT00806377
- Acronym / sponsor ID
- Dinosur / EP001
- Conditions
- Implantable Cardioverter-Defibrillators
- Keywords
- Electromagnetic field, Oversensing, Non-thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Dec 2008 (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 study is:
- To document the incidence of electromagnetic oversensing of ICDs during non-thoracic surgery.
- To identify any non-thoracic procedure with a higher incidence of generating electromagnetic oversensing.
- To document the ability of dual chamber ICDs to discriminate electromagnetic oversensing.
Detailed description
Electrocautery devices used during surgery generate a high electromagnetic field with a frequency that may result in ICD oversensing. Oversensing may in turn result in false detection of a ventricular arrhythmia and for the ICD to discharge. Because of this possibility, patients frequently have their ICDs inactivated prior to the procedure.
Although oversensing appears to be highly unlikely in clinical practice, vast resources are utilized in the process of deactivating and reactivating ICDs for surgeries. In addition, there are reports of deaths from failure to reactivate ICDs following elective surgery.
In this study we intend to document the incidence of oversensing, identify procedures with a higher likelihood of oversensing and evaluate the ability of dual chamber ICDs to discriminate electromagnetic oversensing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective, non-thoracic surgical procedures will be enrolled.
Key inclusion criteria (1 listed)
- Patients with Medtronic or Boston Scientific single and dual chamber ICDs
Key exclusion criteria (2 listed)
- Non-thoracic ICD generator placement (abdominal)
- Pregnant
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
Electromagnetic oversensing will be reported as a percentage of the total enrolled patients
Time frame: Assessed at time of procedure
2 secondary outcomes
Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing
Time frame: Assessed at time of procedure
Incidence of dual chamber ICDs discriminating electromagnetic oversensing.
Time frame: At time of procedure
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 31 May 2017.
- Background: PubMed 15009852Fiek M, Dorwarth U, Durchlaub I, Janko S, Von Bary C, Steinbeck G, Hoffmann E. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs? Pacing Clin Electrophysiol. 2004 Mar;27(3):293-8. doi: 10.1111/j.1540-8159.2004.00430.x.
- Background: PubMed 15851191Hauser RG, Kallinen L. Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database. Heart Rhythm. 2004 Oct;1(4):399-405. doi: 10.1016/j.hrthm.2004.05.006.
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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.
William T Katsyiannis, MD principal investigator
Minneapolis Heart Institute
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 Implantable Cardioverter-Defibrillators, run by Minneapolis Heart Institute Foundation 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 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: finished, as of the sponsor's last update on 31 May 2017. 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?
Electromagnetic oversensing will be reported as a percentage of the total enrolled patients (time frame: Assessed at time of procedure). 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 NCT00806377, 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 31 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.