Defibrillators, ImplantableNCT03271619
Electrical Safety of Implantable Cardioverter Defibrillators
An observational study of Defibrillators, Implantable and Cardiac Arrest, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients at risk of developing life-threatening heart rhythms may require the implantation of a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart rhythm and delivers an electrical shock to the heart when indicated, in order to return the heart back to a normal rhythm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Defibrillators, Implantable, Cardiac Arrest
- What is being tested?
- Surface current measurement
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with implanted defibrillators (ICDs) undergoing defibrillation testing.
Who may be able to join
- Patients with implanted defibrillators (ICDs) undergoing defibrillation testing
- Patients undergoing ICD implantation that requires a defibrillation test at the end of the implantation.
Who cannot join
- Enrolment in other ICD-related studies
- Patients <18 yrs age
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
About this study
Official title: Electrical Safety of Rescuers in Contact With Patients During Implanted Cardioverter Defibrillator Discharge
Patients at risk of developing life-threatening heart rhythms may require the implantation of a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart rhythm and delivers an electrical shock to the heart when indicated, in order to return the heart back to a normal rhythm. Many thousands of these devices have been implanted and are electrically active in patients who collapse and need resuscitation.
When a patient with an ICD collapses, the device may discharge without warning while a rescuer is performing external chest compressions (cardiac massage). Conventional ICDs placed below the left collar bone typically deliver 35-50 J energy when they discharge, but newer ICDs placed under the skin (S-ICD) alongside the breastbone deliver a larger energy when discharging; typically 50-80J energy.
Read more
Rescuers performing external chest compressions on a patient during conventional ICD discharge have reported the sensation of a painful electrical shock and permanent nerve damage. In these situations, rescuers appear to have been exposed to electrical current from the ICD considerably in excess of that which is considered a safe threshold.
Studies of surface current resulting from discharge of conventional ICDs have been reported in excess of 100 mA which is far in excess of the safe 1 mA limit, and puts the rescuer at considerable risk of tissue damage and possible dangerous heart rhythms. The newer S-ICDs deliver approximately 50% more energy and have the potential to result in exposure of a rescuer to even higher currents.
With increasing numbers of the S-ICDs being implanted, and the inevitability that rescuers will soon find themselves exposed to leakage current from these devices, there is a need to examine the leakage currents arising from these devices and assess any subsequent risk to a rescuer performing external chest compressions.
Read the detailed description
Rationale for Study:
When patients undergo elective implantation of an ICD, the device is tested by inducing ventricular fibrillation (VF) in the patient and allowing the ICD to sense, charge and discharge in an attempt to shock the patient back into a normal rhythm. This provides a controlled, elective situation in which to measure the cutaneous current on the patient's skin which is the current to which a rescuer could potentially be exposed.
By understanding the leakage currents from these devices, the investigators will be able to better understand the safety of rescuers in contact with patients fitted with an ICD and make specific recommendations to enable to safe undertaking of uninterrupted external chest compressions while the ICD may be discharging.
STUDY OBJECTIVES
Primary Objective:
To measure cutaneous leakage current on the chest wall during conventional and S-ICD discharge.
Secondary Objectives:
To make recommendations based on this data regarding the safety of rescuers in contact with a patient during ICD discharge.
ENDPOINTS
Primary Endpoint:
Maximum cutaneous current measured at multiple sites on the chest wall during ICD discharge.
STUDY DESIGN This is a prospective cohort study, aiming to study sequential patients undergoing elective ICD implantation and testing over a 12 month period at University Hospital Southampton.
The patient will undergo elective ICD implantation according to normal protocol. There will be no change in their treatment. After induction of general anaesthesia, an array of small self-adhesive electrodes (similar to ECG 'dots') will be placed on the patient's chest wall, and connected to a multichannel recording device.
After implantation of the ICD, the device will be tested as per normal protocol. VF is induced in the patient. The ICD senses this arrhythmia, charges and immediately delivers a shock to the myocardium. As this shock is delivered, the investigators will record the current reaching the surface electrode array using the multichannel recorder. Most patients only require one shock as defibrillation rates with ICDs are >90%. If a second shock is required, the ICD will charge automatically and discharge once again. If this occurs, the investigators will also measure the cutaneous current at this second, higher energy level. The study is then concluded. Any subsequent shocks are delivered through external paddles and the investigators would not require any data from this stage of the procedure.
STUDY POPULATION Number of Participants The investigators aim to assess 20 patients undergoing conventional ICD implantation and a further 20 patients undergoing S-ICD implantation.
- Conditions
- Defibrillators, Implantable, Cardiac Arrest
- Being tested
- Surface current measurement
- Keywords
- Safety Issues
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface current measurementOther
Measurement of surface current between electrodes placed on the chest wall during defibrillation
| Study group | Role | What they receive |
|---|---|---|
| Transvenous ICD | Patients with a transvenous ICD undergoing defibrillation testing. Receives: Other: Surface current measurement | |
| Subcutaneous ICD | Patients with a subcutaneous ICD undergoing defibrillation testing. Receives: Other: Surface current measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface current during defibrillation
To measure cutaneous leakage current on the chest wall during conventional and S-ICD discharge.
Measured: Approximately 10 mSec as the ICD discharges (i.e. at the time of testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study startFeb 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Defibrillators, ImplantableStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Deakin, MD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271619
- Sponsor's protocol ID
- 13/SC/0427
- Status last verified
- Jan 2018
- First submitted
- 29 Aug 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Please contact researchers directly
Publications
Willcox ME, Prutkin JM, Bardy GH. Recent developments in the subcutaneous ICD. Trends Cardiovasc Med. 2016 Aug;26(6):526-35. doi: 10.1016/j.tcm.2016.03.004. Epub 2016 Mar 15.
PubMed 27079889Chue CD, Kwok CS, Wong CW, Patwala A, Barker D, Zaidi A, Mamas MA, Cunnington C, Ahmed FZ. Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review. Heart. 2017 Sep;103(17):1315-1322. doi: 10.1136/heartjnl-2016-310852. Epub 2017 Jul 7.
PubMed 28687562Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.
PubMed 26477420Clements PA. Hazards of performing chest compressions in collapsed patients with internal cardioverter defibrillators. Emerg Med J. 2003 Jul;20(4):379-80. doi: 10.1136/emj.20.4.379. No abstract available.
PubMed 12835365Stockwell B, Bellis G, Morton G, Chung K, Merton WL, Andrews N, Smith GB. Electrical injury during "hands on" defibrillation-A potential risk of internal cardioverter defibrillators? Resuscitation. 2009 Jul;80(7):832-4. doi: 10.1016/j.resuscitation.2009.04.010. Epub 2009 May 14.
PubMed 19446388Niwano S, Kojima J, Inuo K, Saito J, Kashiwa T, Suyama M, Toyoshima T, Aizawa Y, Izumi T. Measurement of body surface energy leakage of defibrillation shock by an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2002 Aug;25(8):1212-8. doi: 10.1046/j.1460-9592.2002.01212.x.
PubMed 12358172
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Safety of Rescuers in Contact With Patients During Implanted Cardioverter Defibrillator Discharge
- ClinicalTrials.gov ID
- NCT03271619
- Acronym / sponsor ID
- 13/SC/0427
- Conditions
- Defibrillators, Implantable, Cardiac Arrest
- Keywords
- Safety Issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 5 Sep 2017 (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.
Patients at risk of developing life-threatening heart rhythms may require the implantation of a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart rhythm and delivers an electrical shock to the heart when indicated, in order to return the heart back to a normal rhythm. Many thousands of these devices have been implanted and are electrically active in patients who collapse and need resuscitation.
When a patient with an ICD collapses, the device may discharge without warning while a rescuer is performing external chest compressions (cardiac massage). Conventional ICDs placed below the left collar bone typically deliver 35-50 J energy when they discharge, but newer ICDs placed under the skin (S-ICD) alongside the breastbone deliver a larger energy when discharging; typically 50-80J energy.
Rescuers performing external chest compressions on a patient during conventional ICD discharge have reported the sensation of a painful electrical shock and permanent nerve damage. In these situations, rescuers appear to have been exposed to electrical current from the ICD considerably in excess of that which is considered a safe threshold.
Studies of surface current resulting from discharge of conventional ICDs have been reported in excess of 100 mA which is far in excess of the safe 1 mA limit, and puts the rescuer at considerable risk of tissue damage and possible dangerous heart rhythms. The newer S-ICDs deliver approximately 50% more energy and have the potential to result in exposure of a rescuer to even higher currents.
With increasing numbers of the S-ICDs being implanted, and the inevitability that rescuers will soon find themselves exposed to leakage current from these devices, there is a need to examine the leakage currents arising from these devices and assess any subsequent risk to a rescuer performing external chest compressions.
Detailed description
Rationale for Study:
When patients undergo elective implantation of an ICD, the device is tested by inducing ventricular fibrillation (VF) in the patient and allowing the ICD to sense, charge and discharge in an attempt to shock the patient back into a normal rhythm. This provides a controlled, elective situation in which to measure the cutaneous current on the patient's skin which is the current to which a rescuer could potentially be exposed.
By understanding the leakage currents from these devices, the investigators will be able to better understand the safety of rescuers in contact with patients fitted with an ICD and make specific recommendations to enable to safe undertaking of uninterrupted external chest compressions while the ICD may be discharging.
STUDY OBJECTIVES
Primary Objective:
To measure cutaneous leakage current on the chest wall during conventional and S-ICD discharge.
Secondary Objectives:
To make recommendations based on this data regarding the safety of rescuers in contact with a patient during ICD discharge.
ENDPOINTS
Primary Endpoint:
Maximum cutaneous current measured at multiple sites on the chest wall during ICD discharge.
STUDY DESIGN This is a prospective cohort study, aiming to study sequential patients undergoing elective ICD implantation and testing over a 12 month period at University Hospital Southampton.
The patient will undergo elective ICD implantation according to normal protocol. There will be no change in their treatment. After induction of general anaesthesia, an array of small self-adhesive electrodes (similar to ECG 'dots') will be placed on the patient's chest wall, and connected to a multichannel recording device.
After implantation of the ICD, the device will be tested as per normal protocol. VF is induced in the patient. The ICD senses this arrhythmia, charges and immediately delivers a shock to the myocardium. As this shock is delivered, the investigators will record the current reaching the surface electrode array using the multichannel recorder. Most patients only require one shock as defibrillation rates with ICDs are >90%. If a second shock is required, the ICD will charge automatically and discharge once again. If this occurs, the investigators will also measure the cutaneous current at this second, higher energy level. The study is then concluded. Any subsequent shocks are delivered through external paddles and the investigators would not require any data from this stage of the procedure.
STUDY POPULATION Number of Participants The investigators aim to assess 20 patients undergoing conventional ICD implantation and a further 20 patients undergoing S-ICD implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvenous ICD | – | Other: Surface current measurementPatients with a transvenous ICD undergoing defibrillation testing. |
| Subcutaneous ICD | – | Other: Surface current measurementPatients with a subcutaneous ICD undergoing defibrillation testing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with implanted defibrillators (ICDs) undergoing defibrillation testing.
Key inclusion criteria (2 listed)
- Patients with implanted defibrillators (ICDs) undergoing defibrillation testing
- Patients undergoing ICD implantation that requires a defibrillation test at the end of the implantation.
Key exclusion criteria (2 listed)
- Enrolment in other ICD-related studies
- Patients <18 yrs age
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 |
|---|---|---|
| Surface current measurementMeasurement of surface current between electrodes placed on the chest wall during defibrillation | Other | Subcutaneous ICD, Transvenous ICD |
Primary outcome
Surface current during defibrillation
Time frame: Approximately 10 mSec as the ICD discharges (i.e. at the time of testing)
To measure cutaneous leakage current on the chest wall during conventional and S-ICD discharge.
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 11 Jan 2018.
- Background: PubMed 27079889Willcox ME, Prutkin JM, Bardy GH. Recent developments in the subcutaneous ICD. Trends Cardiovasc Med. 2016 Aug;26(6):526-35. doi: 10.1016/j.tcm.2016.03.004. Epub 2016 Mar 15.
- Background: PubMed 28687562Chue CD, Kwok CS, Wong CW, Patwala A, Barker D, Zaidi A, Mamas MA, Cunnington C, Ahmed FZ. Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review. Heart. 2017 Sep;103(17):1315-1322. doi: 10.1136/heartjnl-2016-310852. Epub 2017 Jul 7.
- Background: PubMed 26477420Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 12835365Clements PA. Hazards of performing chest compressions in collapsed patients with internal cardioverter defibrillators. Emerg Med J. 2003 Jul;20(4):379-80. doi: 10.1136/emj.20.4.379. No abstract available.
- Background: PubMed 19446388Stockwell B, Bellis G, Morton G, Chung K, Merton WL, Andrews N, Smith GB. Electrical injury during "hands on" defibrillation-A potential risk of internal cardioverter defibrillators? Resuscitation. 2009 Jul;80(7):832-4. doi: 10.1016/j.resuscitation.2009.04.010. Epub 2009 May 14.
- Background: PubMed 12358172Niwano S, Kojima J, Inuo K, Saito J, Kashiwa T, Suyama M, Toyoshima T, Aizawa Y, Izumi T. Measurement of body surface energy leakage of defibrillation shock by an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2002 Aug;25(8):1212-8. doi: 10.1046/j.1460-9592.2002.01212.x.
- Individual participant dataSharing planned: Undecided. Please contact researchers directly
Related trials for Defibrillators, Implantable
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Active, not recruitingObservational study
TRAjectories and CLinical ExpeRiences of ICD Therapy Study
Implantable Defibrillator User
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
RecruitingObservational study
Observational BELgian Registry of Implanted EV-ICD to Evaluate Parameters and Complications of the New Device in Real World Settings
Implantable Cardioverter Defibrillator (ICD)
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.
Charles Deakin, MD principal investigator
University Hospital Southampton NHS Foundation Trust
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 Defibrillators, Implantable and Cardiac Arrest, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 2 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 11 Jan 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 Kingdom. 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?
Surface current during defibrillation (time frame: Approximately 10 mSec as the ICD discharges (i.e. at the time of testing)). 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 NCT03271619, which also lists 6 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 11 Jan 2018.