ICD Shock Detection by a Wearable

Lois Medical LTD20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cardiac Arrest Heart Arrest Cardiopulmonary Arrest

Interventions

Device WearersDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Sensitivity of investigational device at detecting ICD shocks

The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events

Time frame: 1 year

Central Contacts

Dimitrious Panagopoulos, PhD

CONTACT

020 3313 1000 d.panagopoulos@nhs.net

Data from ClinicalTrials.gov

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