Cardiac Arrest, Cardiopulmonary Arrest, Heart Arrest
Conditions
Keywords
ICD, Defibrillator
Brief summary
Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD
Detailed description
Non-invasive, pain-free clinical evaluation of a wearable/proximity sensor designed to detect a high voltage therapeutic shock received by a patient from their Implantable Cardioverter Defibrillator (ICD) during defibrillation threshold testing (DFT), which is a routine part of the clinical procedure.
Interventions
DEVICEDevice Wearers
The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.
Sponsors
Lois Medical LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Each patient will knowingly wear the ICD Smartband
Intervention model description
A single group of patients will wear the LOIS ICD smartband during elective ICD defibrillation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Capable of understanding procedure and making informed consent * Listed for elective ICD Implant * Having routine DFT as part of elective ICD implantation
Exclusion criteria
* Not indicated for ICD implant * Incapable of making informed consent * Pregnant * Not on stabilised anti-coagulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of investigational device at detecting ICD shocks | 1 year | The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events |
Countries
United Kingdom
Contacts
Primary ContactDimitrious Panagopoulos, PhD
Outcome results
None listed