LOIS ICD
Research type
Research Study
Full title
Clinical Evaluation of the LOIS Smartband in patients undergoing elective ICD implantation.
IRAS ID
280629
Contact name
Phang Boon Lim
Contact email
Sponsor organisation
LOIS Medical ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
0 years, 6 months, days
Research summary
Implantable Cardioverter Defibrillators (ICD) are specialised implantable devices which monitor the heart rhythm continuously and are implanted to prevent Sudden Cardiac Death due to abnormal heart rhythms. If they detect a life-threatening heart rhythm, they are designed to deliver a life-saving shock therapy to reset the circuit of the heart. Although recovery following these events is usually quick, there are times when immediate medical assistance may be necessary. The shock itself and the fast heart rhythm can cause incapacity. In some rare cases, trauma or aspiration can be caused from collapsing due to abrupt loss of consciousness. ICDs have the capability to contact the clinical team once a therapy has been delivered. This, however, requires an internet connection and for the patient to be in close proximity to their terminal at home. Furthermore, this service is not active out of hours or weekends. Therefore, it cannot be considered an emergency access service and sometimes it may take some time before the hospital team is aware that a device has delivered a therapy.
The aim of the study is a non-invasive evaluation of a wearable proximity sensor, in the form of a wristband, designed to detect a therapeutic shock received by a patient from their ICD during defibrillation threshold testing, which is a routine part of the clinical procedure during implant of the ICD. The overall purpose of the device when in clinical use will be to alert the next of kin or health providers in real time that a shock has taken place so urgent aid can be sought. As a first step, we have to determine that the LOIS ICD Smartband does, in fact, effectively detect an ICD discharge. It has been bench tested with excellent outcomes but has not been tested whilst being worn by a patient.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
20/NW/0189
Date of REC Opinion
1 May 2020
REC opinion
Favourable Opinion