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NCT Number: NCT06692374

Automated Cardiac Arrest Detection and Alerting in Daily Life

Surviving a cardiac arrest that happens outside the hospital depends on quickly recognizing the event and immediately starting CPR. Survival rates have improved when cardiac arrest is witnessed, but when it isn't, help often arrives too late. Wearable biosensors, like special wristbands, could detect cardiac arrest automatically and alert emergency responders, providing faster help.

In the already finished DETECT-1 study, the investigators developed a system that uses wrist-worn sensors to identify cardiac arrest. The goal of the current study is to test how well this system works in people who have an implantable cardioverter defibrillator (ICD). An ICD is a device that monitors and treats dangerous heart rhythms. Study participants will wear a medical wristband with sensors that monitor the heartrate and movement during their daily activities to see if the system accurately detects cardiac arrest.

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Key information

Conditions

Cardiac Arrest (CA) Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Death, Cardiac

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Survival from out-of-hospital cardiac arrest (OHCA) depends on fast recognition of cardiac arrest and immediate initiation of cardiopulmonary resuscitation (CPR). While survival chances for witnessed OHCA have increased, unwitnessed cases still often receive help too late. Wearable biosensor technology with the functionality of automated cardiac arrest detection and activation of the emergency medical chain would offer a potential solution to provide early help. In the recently published DETECT-1 study, an algorithm for automated cardiac arrest detection using wrist-derived photoplethysmography (PPG) was recently developed.

The current study is a prospective multicenter observational cohort study to validate the sensitivity of the developed cardiac arrest detection algorithm in patients with an implantable cardioverter defibrillator (ICD) during daily life. The study population includes patients with an ICD. Study participants will wear a medical wristband with PPG and accelerometer sensors during daily life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with an implantable cardioverter defibrillator (ICD)
  • Age 18 years or older
  • Fitting the wristband
  • In possession of a smartphone that is compatible with the wristband

Exclusion criteria

  • Known hemodynamically relevant bilateral subclavian artery stenosis
  • Medical issues that interfere with wearing of the wristband (e.g. skin disorders)
  • Insufficient skills to operate with the device/app

Treatment and study plan

Primary outcomes

  1. Sensitivity for cardiac arrest detection

    Time frame: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)

    The number of correctly identified cardiac arrest events by the algorithm devided by the total number of cardiac arrest events.

Secondary outcomes

  1. Positive predictive value for cardiac arrest detection

    Time frame: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)

    The number of true positives devided by the sum of the true positives and false positive cardiac arrest alarms

  2. False positive alarm rate

    Time frame: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)

    Expressed as the number of false positive non-cancelled cardiac arrest alarms per user year

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Corsano Health

Registry information

Official study title

Smartwatch-based Automated Cardiac Arrest Detection and Activation of the Emergency Medical Chain: Validation in a Home Setting

Acronym: DETECT-4b

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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