The Intrepid Clinical Engineering Study

Sudden Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05636332
• Other study ID #: CCTCECRIntrepid 12Lead2022
• Status: Completed
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: November 2, 2022

Study information

• Verified date: March 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Days to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Arrest

Intervention

Diagnostic Test:
• 12 lead Electrocardiogram
12 lead Electrocardiogram

Locations

Country	Name	City	State
United States	Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)	Lehigh Acres	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of Algorithm Software Update	Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.	day 1
Primary	Diagnostic Quality	Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.	day 1
Secondary	Adverse Events	Participants with frequency and severity of unexpected adverse events	day 1
Secondary	Unanticipated Adverse Device Effects (UADE)	Participants with unanticipated adverse device effects (UADE).	day 1