Novel ICD Arrhythmia Detection Algorithm

  • STATUS
    Recruiting
  • End date
    Oct 7, 2023
  • participants needed
    100
  • sponsor
    Imperial College London
Updated on 6 August 2021
arrhythmia
ventricular tachycardia
sudden cardiac death

Summary

Implantable cardioverter defibrillators (ICD) are used to treat life-threatening heart rhythm disturbances (arrhythmias).

They have been proven to reduce the risk of sudden cardiac death however, there are limitations with current ICDs. Firstly, they may deliver inappropriate therapies (therapies delivered in the absence of life-threatening arrhythmias). Secondly, slower life-threatening arrhythmias may be left untreated because current programming recommendations, designed to minimise inappropriate therapies, rely predominantly on heart rates. Therefore, there is considerable potential to make ICDs safer with more sophisticated ICD algorithms.

In this research study we will collect data from patients with newly implanted or existing ICDs whilst they are in induced or spontaneously occurring abnormal rhythms. The data will come from sensors placed on the skin that can measure blood flow or electrical properties of the body. In addition, in 20 patients we will also collect further data from a small loop recorder implanted under the skin.

We will use this data to help develop and validate new methods of reliably identifying life-threatening arrhythmias so that future ICDs deliver therapies when only needed.

The research is funded by the British Heart Foundation, and will take place at Hammersmith Hospital over 3 years. We aim to recruit 100 patients in total.

Description

This novel arrhythmia detection algorithm will incorporate a haemodynamic sensor and extra bipolar electrogram with an aim to outperform current commercially used arrhythmia detection algorithms that rely primarily on heart rate.

Details
Condition Cardiac Disease, Implantable Defibrillator User, impulse control disorder, Cardiomyopathy, impulse control disorders, cardiomyopathies, mucolipidosis ii, myocardial diseases, Heart disease, Mucolipidosis, Heart Disease, ICD-10
Clinical Study IdentifierNCT04981496
SponsorImperial College London
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Study A and B
Patients referred for conventional defibrillator implantation or generator change
Adults (age > 18 years)
Willing to take part and able to give consent
Study C
Patients with defibrillators who are undergoing a VT ablation
Adults (age > 18 years)
Willing to take part and able to give consent
Study D
Patients with defibrillators already implanted who are able to exercise and raise their heart rate substantially
Adults (age > 18 years)
Willing to take part and able to give consent
Study E
Patients with a defibrillator already implanted admitted with atrial arrhythmias, ventricular tachycardia or RV lead fracture
Adults (age > 18 years)
Willing to take part and able to give consent

Exclusion Criteria

Exclusion criteria for studies A-E
Unable to give consent
Children (age < 18 years)
Pregnant women
Exclusion criteria for studies A and B if undergoing VF induction
Intracardiac thrombus
AF without regular anticoagulation
Severe aortic stenosis
Severe ischaemic heart disease
Decompensated heart failure
Exclusion criteria for study D
Recent heart attack or stroke (within the last month)
Thromboembolic event undergoing active treatment
Severe aortic stenosis
Severe ischaemic heart disease
Hypertrophic obstructive cardiomyopathy
Uncontrolled ventricular arrhythmias
Physically unable to exercise, for example due to arthritis
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