ICD Shock Detection by a Wearable (LOISICD)

March 22, 2021 updated by: Lois Medical LTD

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
          • Dimitrious Panagopoulos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of investigational device at detecting ICD shocks
Time Frame: 1 year
The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lois Medical LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 264962

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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