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NCT04565652 Clinical Trial

ICD Shock Detection by a Wearable

Cardiac Arrest Clinical Trial

— LOISICD  

Official title:
Clinical Evaluation of the LOIS Smartband in Patients Undergoing Elective ICD Implantation With Defibrillation (DFT) Threshold Testing.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04565652
Other study ID # 264962
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2021
Est. completion date December 2021

Study information
Verified date March 2021
Source Lois Medical LTD
Contact Dimitrious Panagopoulos, PhD
Phone 020 3313 1000
Email d.panagopoulos@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Device Wearers
The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.

Locations
Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London

Sponsors (1)
Lead Sponsor Collaborator
Lois Medical LTD

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of investigational device at detecting ICD shocks The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events 1 year
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