Sudden Cardiac ArrestNCT05587764
Tempus Pro Monitor Registry
An observational study of Sudden Cardiac Arrest and Emergency Care, run by Heartstream US LLC at 1 site in United States.
Trial summary
A multicenter, prospective and retrospective, observational, post market study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sudden Cardiac Arrest, Emergency Care
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2024to 12 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pre- and inter-hospital transfer: emergency patients (adults and pediatrics).
Who may be able to join
- Patients monitored by using Tempus Pro during pre-hospital care (ambulance transportation)
- One or more 12-lead ECG recorded
- Use of 3 or more of the following sensors to measure vital signs
- NIBP (Non-Invasive Blood Pressure)
- HR (Heart Rate)
- SpO2 (Oxygen Saturation)
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- PVI (Pleth Variability Index)
- SpCO (Carboxyhemoglobin)
- SpOC (Oxygen Content)
- SpHb (Total Hemoglobin)
- SpMet (Methemoglobin Saturation)
- EtCO2 (End-tidal Carbon Dioxide)
Who cannot join
- None defined
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Market Clinical Follow-up Study to Evaluate the Safety and Clinical Performance of the Tempus Pro, a Multi-parameter Vital Signs Monitoring Device With Specific Reference to ECG Recordings and Data Transmission Using Telemedicine
A multicenter, prospective and retrospective, observational, post market study.
Read the detailed description
This observational study is to collect real-world data on the safety and performance of the Tempus Pro device, its accessories and the IntelliSpace Corsium telemedicine software device when used according to its intended purpose and the instructions for use, when used for patient monitoring.
- Conditions
- Sudden Cardiac Arrest, Emergency Care
- Being tested
- Standard of Care
- Keywords
- Tempus Pro, IntelliSpace Corsium
- 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.
Standard of CareDiagnostic test
Standard of care for emergency events per local guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Standard of Care for emergency care Receives: Diagnostic Test: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician assessment of 12-lead ECG reports
The proportion of 12-lead ECG pairs that are identical, after a cardiologist's review of printouts from Corsium IntelliSpace (transmitted) ECG and the original ECG from the Tempus Pro device.
Measured: through study completion, an average of 1 year
Diagnostic quality of 12-lead
The printed patient record ECG will be independently reviewed for abnormalities and distortion by a clinician. The clinician will note any abnormalities altering diagnostic quality.
Measured: through study completion, an average of 1 year
Consistency of transmitted vital signs by Tempus Pro via IntelliSpace Corsium
The number and proportion of patient vital sign data points, comparing direct data with identical units of measure from printouts from IntelliSpace Corsium (transmitted) vital signs and the original vital signs from the Tempus Pro device.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Number of all activated alarms
The 'Summary Record of Care' indicates all alarms - for all alarm-settable parameters - were activated at the thresholds set by the user, as indicated in the 'Technical Log'
Measured: through study completion, an average of 1 year
IntelliSpace Corsium transmission
The Summary Record of Care (SRoC) data transmission from Tempus Pro to IntelliSpace Corsium will be independently reviewed for abnormalities and distortion by a clinician. The clinician will note any abnormalities altering diagnostic quality of the transmission.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start25 Apr 2024
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 103 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Heartstream US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Clinical & Medical Affairs Global, North American Science Associates Ltd.
- Responsible party
- Sponsor
- Investigators
- Richard Lyon, MB CHB (HONS) MD MRCP FRCEM, Principal investigator, CONSULTANT IN EMERGENCY MEDICINE, NHS LOTHIAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587764
- Sponsor's protocol ID
- CCTCRDTTempusProRegi20211168
- Status last verified
- Aug 2026
- First submitted
- 13 Oct 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Clinical Follow-up Study to Evaluate the Safety and Clinical Performance of the Tempus Pro, a Multi-parameter Vital Signs Monitoring Device With Specific Reference to ECG Recordings and Data Transmission Using Telemedicine
- ClinicalTrials.gov ID
- NCT05587764
- Acronym / sponsor ID
- CCTCRDTTempusProRegi20211168
- Conditions
- Sudden Cardiac Arrest, Emergency Care
- Keywords
- Tempus Pro, IntelliSpace Corsium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Heartstream US LLCIndustry (pharma, biotech, devices)
- Collaborators
- Philips Clinical & Medical Affairs Global, North American Science Associates Ltd.
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, prospective and retrospective, observational, post market study.
Detailed description
This observational study is to collect real-world data on the safety and performance of the Tempus Pro device, its accessories and the IntelliSpace Corsium telemedicine software device when used according to its intended purpose and the instructions for use, when used for patient monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | Diagnostic Test: Standard of CareStandard of Care for emergency care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pre- and inter-hospital transfer: emergency patients (adults and pediatrics).
Key inclusion criteria (12 listed)
- Patients monitored by using Tempus Pro during pre-hospital care (ambulance transportation)
- One or more 12-lead ECG recorded
- Use of 3 or more of the following sensors to measure vital signs
- NIBP (Non-Invasive Blood Pressure)
- HR (Heart Rate)
Key exclusion criteria (1 listed)
- None defined
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 |
|---|---|---|
| Standard of CareStandard of care for emergency events per local guidelines. | Diagnostic test | Standard of Care |
Primary outcome
Clinician assessment of 12-lead ECG reports
Time frame: through study completion, an average of 1 year
The proportion of 12-lead ECG pairs that are identical, after a cardiologist's review of printouts from Corsium IntelliSpace (transmitted) ECG and the original ECG from the Tempus Pro device.
Diagnostic quality of 12-lead
Time frame: through study completion, an average of 1 year
The printed patient record ECG will be independently reviewed for abnormalities and distortion by a clinician. The clinician will note any abnormalities altering diagnostic quality.
Consistency of transmitted vital signs by Tempus Pro via IntelliSpace Corsium
Time frame: through study completion, an average of 1 year
The number and proportion of patient vital sign data points, comparing direct data with identical units of measure from printouts from IntelliSpace Corsium (transmitted) vital signs and the original vital signs from the Tempus Pro device.
2 secondary outcomes
Number of all activated alarms
Time frame: through study completion, an average of 1 year
IntelliSpace Corsium transmission
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Richard Lyon, MB CHB (HONS) MD MRCP FRCEM principal investigator
CONSULTANT IN EMERGENCY MEDICINE, NHS LOTHIAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Arrest and Emergency Care, 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 12 inclusion and 1 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 21 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinician assessment of 12-lead ECG reports (time frame: through study completion, an average of 1 year). The study lists 3 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 21 Aug 2026.