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Completed

NCT Number: NCT05636332

The Intrepid Clinical Engineering Study

The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.

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Key information

Conditions

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

Age range

29 day–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)

Lehigh Acres, Florida, 33971, United States

About this study

The purpose of this study is to validate the Philips DXL electrocardiogram Algorithm works as intended in the HeartStart Intrepid Monitor/Defibrillator after a software update was completed to address instances of high impedance. This study will also determine the diagnostic quality of the 12-lead electrocardiogram tracing from the HeartStart Intrepid Monitor/Defibrillator.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to read, write, speak, and understand English
  • Age: 29 days to 89 years
  • Willing and able to provide informed consent and complete study procedures
  • Willing to have Philips representatives present during study procedures.

Exclusion criteria

  • Known allergy to medical adhesives, silicone, or latex (per self-report)
  • Any limitation or medical condition, including but not limited to physical or cognitive disability, that would affect the participant's ability to complete study activities (per investigator)
  • At the time of enrollment, current enrollment in any other interventional research study
  • An employee, or residing family member of an employee, of a company that designs, sells, or manufactures monitor/defibrillator technology or related products (including Philips)

Treatment and study plan

12 lead Electrocardiogram

Diagnostic Test

12 lead Electrocardiogram

Primary outcomes

  1. Validation of Algorithm Software Update

    Time frame: day 1

    Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.

  2. Diagnostic Quality

    Time frame: day 1

    Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.

Secondary outcomes

  1. Adverse Events

    Time frame: day 1

    Participants with frequency and severity of unexpected adverse events

  2. Unanticipated Adverse Device Effects (UADE)

    Time frame: day 1

    Participants with unanticipated adverse device effects (UADE).

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2022
Registry last updated
Mar 25, 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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