Sudden Cardiac ArrestNCT05636332
The Intrepid Clinical Engineering Study
A study testing 12 lead Electrocardiogram in people with Sudden Cardiac Arrest, run by Heartstream US LLC at 1 site in United States.
Trial summary
The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring. Read more about this study
- Who is it for?
- Ages 29 days to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Arrest
- What is being tested?
- 12 lead Electrocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
Lehigh Acres, Florida, 33971
About this study
Official title: Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (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.
Read the 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
- Sudden Cardiac Arrest
- Being tested
- 12 lead Electrocardiogram
- Keywords
- Monitor
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 lead ElectrocardiogramDiagnostic test
12 lead Electrocardiogram
| Study group | Role | What they receive |
|---|---|---|
| New electrodes | Other | New package of electrodes Receives: Diagnostic Test: 12 lead Electrocardiogram |
| 24-hour opened electrodes | Other | Electrodes opened 24 hours Receives: Diagnostic Test: 12 lead Electrocardiogram |
| 30 day opened electrodes | Other | Electrodes opened 30 days Receives: Diagnostic Test: 12 lead Electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of Algorithm Software Update
Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.
Measured: day 1
Diagnostic Quality
Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.
Measured: day 1
Secondary outcomes (2)
Adverse Events
Participants with frequency and severity of unexpected adverse events
Measured: day 1
Unanticipated Adverse Device Effects (UADE)
Participants with unanticipated adverse device effects (UADE).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start3 Oct 2022
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sudden Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartstream US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Clinical & Medical Affairs Global
- Responsible party
- Sponsor
- Investigators
- Alaa El-Gendy, MD, MSc, FCCP, Principal investigator, Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636332
- Sponsor's protocol ID
- CCTCECRIntrepid 12Lead2022
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2022
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study
- ClinicalTrials.gov ID
- NCT05636332
- Acronym / sponsor ID
- CCTCECRIntrepid 12Lead2022
- Conditions
- Sudden Cardiac Arrest
- Keywords
- Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Heartstream US LLCIndustry (pharma, biotech, devices)
- Collaborators
- Philips Clinical & Medical Affairs Global
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Posted 25 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New electrodes | Other | Diagnostic Test: 12 lead ElectrocardiogramNew package of electrodes |
| 24-hour opened electrodes | Other | Diagnostic Test: 12 lead ElectrocardiogramElectrodes opened 24 hours |
| 30 day opened electrodes | Other | Diagnostic Test: 12 lead ElectrocardiogramElectrodes opened 30 days |
Who may qualify
- Ages
- 29 days to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 lead Electrocardiogram12 lead Electrocardiogram | Diagnostic test | 24-hour opened electrodes, 30 day opened electrodes, New electrodes |
Primary outcome
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.
Diagnostic Quality
Time frame: day 1
Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.
2 secondary outcomes
Adverse Events
Time frame: day 1
Unanticipated Adverse Device Effects (UADE)
Time frame: day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sudden Cardiac Arrest
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingObservational study
Cardiovascular Pre-participation Screening in Children and Adolescents
Sudden Cardiac Death, Cardiac Arrhythmias
Recruiting
Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta
AAOCA, ACAOS
RecruitingObservational study
Hypertrophic Cardiomyopathy Registry, Biobank and Imaging Data Repository
Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy
RecruitingPhase 4
Epinephrine Dose: Optimal Versus Standard Evaluation Trial
Cardiac Arrest, Out-Of-Hospital, Sudden Cardiac Arrest
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa El-Gendy, MD, MSc, FCCP principal investigator
Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 lead Electrocardiogram in people with Sudden Cardiac Arrest, run by Heartstream US LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of Algorithm Software Update (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.