ICD Shock Detection by a Wearable

Not Applicable

• Conditions: Cardiac Arrest; Cardiopulmonary Arrest; Heart Arrest
• Interventions: Device: Device Wearers

• Registration Number: NCT04565652
• Lead Sponsor: Lois Medical LTD

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.

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-25
• Status Verified: 2021-03
• Study Start: 2021-03-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICD Defibrillation	Device Wearers	Detection of ICD shock during elective ICD implant using the investigational device

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom