ICD Shock Detection by a Wearable (LOISICD)

LOIS Medical

Status: Unknown

Conditions: Heart Arrest; Cardiopulmonary Arrest; Cardiac Arrest

Treatments: Device: Device Wearers

Study type: Interventional

Funder types: Industry

Identifiers

NCT04565652

264962

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ICD Defibrillation

Experimental group

Description:

Detection of ICD shock during elective ICD implant using the investigational device

Treatment:

Device: Device Wearers