Imperial Electro-Mechanical Coupling Loop Recorder: In Vivo Testing
Research type
Research Study
Full title
Development of the Imperial Implantable Electro-Mechanical Coupling Loop Recorder (ILR) - In Vivo Testing
IRAS ID
299389
Contact name
Zachary Whinnett
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
Ventricular tachycardia (VT) is a potentially life threatening heart rhythm disturbance. VT reduces the heart’s ability to pump efficiently and therefore reduces cardiac output. Implantable cardioverter-defibrillators (ICDs) have been shown to be life-saving for those at risk of developing ventricular arrhythmias. They have two treatments available to return the heart to a normal rhythm (1) anti-tachycardia pacing therapy (ATP) which is a form of pacing therapy and (2) these devices can also deliver a shock in an attempt to restore the heart’s normal rhythm. While these therapies have been shown to be lifesaving, they can be very uncomfortable and may cause harm to patients.
40% of the shocks delivered by implantable cardioverter-defibrillators are unnecessary, because ICDs rely solely on ECG (electrocardiogram) signals for their decisions. They cannot distinguish between artefact, arrhythmias which do not require a shock (because haemodynamic status is maintained) and arrhythmias requiring a shock. Resulting unnecessary shocks distress the patient and damage the heart.
Previous attempts at using haemodynamic markers to limit shocks have not been reliable enough for clinical adoption. We have developed and patented a unique combinatorial algorithm for electrograms alongside haemodynamic signals, that is vastly more reliable than all previous methods. We have proven our solution in humans using externally-placed sensors. The crucial step now is demonstration that it works equally well with internally-placed sensors. We have therefore created an implantable device that monitors haemodynamics and cardiac electrograms, for internal testing in humans.
In this study, we will test the reliability of our proof-of-concept implantable device which can implement our novel combinatorial method. If our technology is shown to be successful using signals from miniaturised sensors, this could be incorporated into future implantable cardioverter-defibrillators. Adding our technology would slash unnecessary shocks at least 10-fold making licensed devices immensely more desirable and safer.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/LO/0438
Date of REC Opinion
27 Jul 2022
REC opinion
Further Information Favourable Opinion