Electrical Safety of Implantable Cardioverter Defibrillators

NCT03271619 | Completed

• 1 other identifier: 13/SC/0427
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Defibrillators, Implantable; Cardiac Arrest

Keywords

Safety Issues

Outcome Measures

Primary Outcomes (1)

• Surface current during defibrillation

  To measure cutaneous leakage current on the chest wall during conventional and S-ICD discharge.

  Approximately 10 mSec as the ICD discharges (i.e. at the time of testing)

Study Arms (2)

Transvenous ICD

Patients with a transvenous ICD undergoing defibrillation testing.

Other: Surface current measurement

Subcutaneous ICD

Patients with a subcutaneous ICD undergoing defibrillation testing.

Other: Surface current measurement

Interventions

Surface current measurement OTHER

Measurement of surface current between electrodes placed on the chest wall during defibrillation

Subcutaneous ICD; Transvenous ICD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with implanted defibrillators (ICDs) undergoing defibrillation testing.

You may qualify if:

• Patients with implanted defibrillators (ICDs) undergoing defibrillation testing
• Patients undergoing ICD implantation that requires a defibrillation test at the end of the implantation.

You may not qualify if:

• Enrolment in other ICD-related studies
• Patients \<18 yrs age

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 27079889 BACKGROUND

• Chue 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.

  PMID: 28687562 BACKGROUND

• Perkins 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.

  PMID: 26477420 BACKGROUND

• Clements 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.

  PMID: 12835365 BACKGROUND

• Stockwell 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.

  PMID: 19446388 BACKGROUND

• Niwano 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.

  PMID: 12358172 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Charles Deakin, MD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: February 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

GB (1)