Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 9:41 AM
Study NCT ID:
NCT05636332
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Intrepid Clinical Engineering Study
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: