Trials / Completed
CompletedNCT05636332
The Intrepid Clinical Engineering Study
Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Philips Clinical & Medical Affairs Global · Industry
- Sex
- All
- Age
- 29 Days – 89 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 12 lead Electrocardiogram | 12 lead Electrocardiogram |
Timeline
- Start date
- 2022-10-03
- Primary completion
- 2022-11-02
- Completion
- 2022-11-02
- First posted
- 2022-12-05
- Last updated
- 2024-03-25
- Results posted
- 2024-03-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05636332. Inclusion in this directory is not an endorsement.