LOISICD: ICD Shock Detection by a Wearable

Sponsor

Lois Medical LTD (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04565652

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest Heart Arrest Cardiopulmonary Arrest	Device: Device Wearers	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A single group of patients will wear the LOIS ICD smartband during elective ICD defibrillationA single group of patients will wear the LOIS ICD smartband during elective ICD defibrillation

Masking:

None (Open Label)

Masking Description:

Each patient will knowingly wear the ICD Smartband

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 3, 2021

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICD Defibrillation Detection of ICD shock during elective ICD implant using the investigational device	Device: Device Wearers The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.

Arm

Intervention/Treatment

Experimental: ICD Defibrillation

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

Device: Device Wearers

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Imperial College Healthcare NHS Trust	London		United Kingdom	W12 0HS

Sponsors and Collaborators

Lois Medical LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lois Medical LTD

ClinicalTrials.gov Identifier:

NCT04565652

Other Study ID Numbers:

264962

First Posted:

Sep 25, 2020

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lois Medical LTD

ICD

Defibrillator

Additional relevant MeSH terms:

Heart Arrest

Study Results

No Results Posted as of Mar 23, 2021