Back to resultsICD Shock Detection by a Wearable (LOISICD)
Primary Purpose
Cardiac Arrest, Heart Arrest, Cardiopulmonary Arrest
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Device Wearers
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiac Arrest focused on measuring ICD, Defibrillator
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
Sites / Locations
- Imperial College Healthcare NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICD Defibrillation
Arm Description
Detection of ICD shock during elective ICD implant using the investigational device
Outcomes
Primary Outcome Measures
Sensitivity of investigational device at detecting ICD shocks
The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04565652
Brief Title
ICD Shock Detection by a Wearable
Acronym
LOISICD
Official Title
Clinical Evaluation of the LOIS Smartband in Patients Undergoing Elective ICD Implantation With Defibrillation (DFT) Threshold Testing.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lois Medical LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Heart Arrest, Cardiopulmonary Arrest
Keywords
ICD, Defibrillator
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A 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
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICD Defibrillation
Arm Type
Experimental
Arm Description
Detection of ICD shock during elective ICD implant using the investigational device
Intervention Type
Device
Intervention Name(s)
Device Wearers
Intervention Description
The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.
Primary Outcome Measure Information:
Title
Sensitivity of investigational device at detecting ICD shocks
Description
The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitrious Panagopoulos, PhD
Phone
020 3313 1000
Email
d.panagopoulos@nhs.net
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitrious Panagopoulos
12. IPD Sharing Statement
Learn more about this trial
ICD Shock Detection by a Wearable
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