Clinical Trials Logo
  1. Home
  2. Cardiac Arrest
  3. NCT04565652
  4. Details
NCT04565652 Clinical Trial

ICD Shock Detection by a Wearable

Cardiac Arrest Clinical Trial

— LOISICD  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04565652
Other study ID # 264962
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2021
Est. completion date December 2021

Study information
Verified date March 2021
Source Lois Medical LTD
Contact Dimitrious Panagopoulos, PhD
Phone 020 3313 1000
Email d.panagopoulos@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London

Sponsors (1)
Lead Sponsor Collaborator
Lois Medical LTD

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06048068 - Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events N/A
Recruiting NCT05558228 - Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Completed NCT03685383 - Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Completed NCT04619498 - Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT02352350 - Lactate in Cardiac Arrest N/A
Completed NCT03024021 - Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Completed NCT02275234 - Care After Resuscitation
Completed NCT02247947 - Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
Completed NCT01944605 - Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest N/A
Completed NCT01972087 - Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest N/A
Completed NCT01936597 - Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage N/A
Active, not recruiting NCT01239420 - Norwegian Cardio-Respiratory Arrest Study
Completed NCT00878644 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial Phase 3
Completed NCT00880087 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial N/A
Completed NCT01191736 - Ultra-Brief Versus Brief Hands Only CPR Video Training With and Without Psychomotor Skill Practice N/A
Completed NCT00729794 - Vasopressin, Epinephrine, and Steroids for Cardiac Arrest Phase 3
Recruiting NCT00441753 - Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest N/A
Completed NCT00347477 - Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest Phase 3