ICD Shock Detection by a Wearable | NCT04565652

Studies
ICD Shock Detection by a Wearable

NCT04565652

Sponsor

Lois Medical LTD

Status

Unknown status

Last Update Posted

Mar 23, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Cardiac Arrest
Heart Arrest
Cardiopulmonary Arrest

Interventions

Device Wearers

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2021Actual

Primary Completion Date

Nov 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Sep 10, 2020

First Submission Date that Met QC Criteria

Sep 22, 2020

First Posted Date

Sep 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2021

Last Update Posted Date

Mar 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICD Defibrillation	Experimental	Detection of ICD shock during elective ICD implant using the investigational device	Device: Device Wearers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Device Wearers	Device	The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.	ICD Defibrillation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dimitrious Panagopoulos, PhD	Contact	020 3313 1000		d.panagopoulos@nhs.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imperial College Healthcare NHS Trust	Recruiting	London		W12 0HS	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided