The Intrepid Clinical Engineering Study
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Treatments
Details and patient eligibility
About
The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.
Full 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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