Cardiac ArrestLOISICDNCT04565652
ICD Shock Detection by a Wearable
A study testing Device Wearers in people with Cardiac Arrest and Heart Arrest, run by Lois Medical LTD at 1 site in United Kingdom.
Trial summary
Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Heart Arrest, Cardiopulmonary Arrest
- What is being tested?
- Device Wearers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of understanding procedure and making informed consent
- Listed for elective ICD Implant
- Having routine DFT as part of elective ICD implantation
Who cannot join
- Not indicated for ICD implant
- Incapable of making informed consent
- Pregnant
- Not on stabilised anti-coagulation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Dimitrious Panagopoulos
About this study
Official title: 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
Read the 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.
- Conditions
- Cardiac Arrest, Heart Arrest, Cardiopulmonary Arrest
- Being tested
- Device Wearers
- Keywords
- ICD, Defibrillator
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device WearersDevice
The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.
| Study group | Role | What they receive |
|---|---|---|
| ICD Defibrillation | Experimental | Detection of ICD shock during elective ICD implant using the investigational device Receives: Device: Device Wearers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of investigational device at detecting ICD shocks
The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start3 Mar 2021
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of patients will wear the LOIS ICD smartband during elective ICD defibrillation
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lois Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565652
- Sponsor's protocol ID
- 264962
- Acronym
- LOISICD
- Status last verified
- Mar 2021
- First submitted
- 10 Sep 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the LOIS Smartband in Patients Undergoing Elective ICD Implantation With Defibrillation (DFT) Threshold Testing.
- ClinicalTrials.gov ID
- NCT04565652
- Acronym / sponsor ID
- LOISICD / 264962
- Conditions
- Cardiac Arrest, Heart Arrest, Cardiopulmonary Arrest
- Keywords
- ICD, Defibrillator
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lois Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of patients will wear the LOIS ICD smartband during elective ICD defibrillation
| Arm | Type | Receives |
|---|---|---|
| ICD Defibrillation | Experimental | Device: Device WearersDetection of ICD shock during elective ICD implant using the investigational device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Capable of understanding procedure and making informed consent
- Listed for elective ICD Implant
- Having routine DFT as part of elective ICD implantation
Key exclusion criteria (4 listed)
- Not indicated for ICD implant
- Incapable of making informed consent
- Pregnant
- Not on stabilised anti-coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device WearersThe intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant. | Device | ICD Defibrillation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device Wearers in people with Cardiac Arrest and Heart Arrest, run by Lois Medical LTD at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitrious Panagopoulos, PhD (020 3313 1000, d.panagopoulos@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of investigational device at detecting ICD shocks (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.