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Trials / Unknown

UnknownNCT04565652

ICD Shock Detection by a Wearable

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Lois Medical LTD · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEDevice WearersThe intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.

Timeline

Start date
2021-03-03
Primary completion
2021-11-01
Completion
2021-12-01
First posted
2020-09-25
Last updated
2021-03-23

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04565652. Inclusion in this directory is not an endorsement.

ICD Shock Detection by a Wearable (NCT04565652) · Clinical Trials Directory