Sudden Cardiac ArrestNCT04840797
HeartStart HS1 Defibrillator* Event Registry
An observational study of Sudden Cardiac Arrest, run by Heartstream US LLC at 1 site in United States.
Trial summary
A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sudden Cardiac Arrest
- What is being tested?
- HeartStart HS1
- Type of treatment
- Medical device
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 31 Dec 2030
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Anyone who is suspected of having a sudden cardiac arrest.
Who may be able to join
- Have been suspected of a circulatory arrest for any cause.
- Have had HeartStart HS1 Defibrillator with electrodes:
- Adult SMART Pads Cartridge [REF: M5071A], Infant/Child SMART Pads Cartridge (REF:M5072A) applied to their body and powered up with HS1 battery (Model M5070A), regardless of whether a defibrillation shock was delivered
Who cannot join
- Subjects will be excluded if any of the following are present:
- AED or pad use other than the HeartStart HS1 Defibrillator with above referenced Philips electrode pads. Note: Use of a device other than the Philips HeartStart HS1 AED does not preclude enrollment if the AED or an Advanced Life Support defibrillator was used after the HeartStart HS1 AED.
- AED used for training purposes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Philips
Pittsburgh, Pennsylvania, 15206
Chase Wennick, 617-398-7347, chase.wennick@philips.com
Gerrit Nordergraaf, MD PhD
About this study
A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.
Read the detailed description
The objective of this PMCF (Post Market Clinical Follow-up) prospective collection of post-event data registry is to confirm the safety and performance as expressed in the energy delivery by the HeartStart HS1 Defibrillator (HeartStart OnSite and Home models in North America) in the population for the device's intended use in reference to its commercial labeling, and in relationship to the type of pads attached to the device.
- Conditions
- Sudden Cardiac Arrest
- Being tested
- HeartStart HS1
- Keywords
- AED, Post -Market, Cardiology
- 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.
HeartStart HS1Device
Automated External Defibrillator
| Study group | Role | What they receive |
|---|---|---|
| Suspected Sudden Cardiac Arrest | All subjects with suspected of a circulatory arrest of any cause. Receives: Device: HeartStart HS1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean shock energy delivered in the pediatric population
Mean of shock energy delivered, when the pediatric defibrillation pads were attached to the AED as intended for infants and children under 25 kilograms / 55 pounds or 0-8 years old.
Measured: Up to 15 minutes during device placement
Mean shock energy delivered in the adult population
Mean of shock energy delivered, when the adult defibrillation pads were attached to the AED as intended for in children and adults over 25 kilograms / 55 pounds or greater than 8 years old.
Measured: Up to 15 minutes during device placement
The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement.
Performance is defined by the sensitivity and specificity; positive predictive value and false positive rate will be reported for each rhythm category (as defined by device labeling).
Measured: Up to 15 minutes during device placement
Accurate detection of shockable rhythms and facilitation of shocks.
The percentage of events where a shockable rhythm was identified by the device, the device advised a shock, and the device delivered a shock when the shock button was pressed.
Measured: Up to 15 minutes during device placement
Defibrillation success
Defibrillation success and the number of shocks required for success.
Measured: Up to 15 minutes during device placement
Secondary outcomes (12)
Frequency and severity of unexpected adverse events
Frequency and severity of unexpected adverse events
Measured: Up to 15 minutes during device placement
Unanticipated adverse device effects (UADE)
Unanticipated adverse device effects (UADE)
Measured: Up to 15 minutes during device placement
Median operating time intervals
Median operating time intervals
Measured: Up to 15 minutes during device placement
Routine self-test performance/Battery Insertion self-test performance
Routine self-test performance/Battery Insertion self-test performance
Measured: Up to 15 minutes during device placement
Device arming after shock advisement.
The percentage of events where the device advised a shock and the device armed.
Measured: Up to 15 minutes during device placement
Energy delivered consistent with device labeling
The percentage of defibrillations in which the energy delivered was consistent with device labeling.
Measured: Up to 15 minutes during device placement
Pad replacement notification
Number of events in which pads were replaced at any time during the event after the user is prompted to do so by the device
Measured: Up to 15 minutes during device placement
Shock button effectively pressed after shock advisement
The percentage of events where a shock was recommended by the device and the shock button was pressed.
Measured: Up to 15 minutes during device placement
Indicators of battery status/depletion (device logged data)
Percentage of events that include indicators of battery status/depletion (device logged data)
Measured: Up to 15 minutes during device placement
Aborted shocks because of low or high impedance
Percentage of aborted shocks because of low or high impedance
Measured: Up to 15 minutes during device placement
CPR guidance initiated (i-button pushed)
Percentage of events where CPR guidance was initiated (i-button pushed)
Measured: Up to 15 minutes during device placement
CPR activity
Percentage of events where CPR is performed during CPR guidance
Measured: Up to 15 minutes during device placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start25 Feb 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
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
- Prospective
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Heartstream US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerrit Noordergraaf, MD PhD, Principal investigator, Philips Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840797
- Sponsor's protocol ID
- TC_ECR_HS1_2020_10819
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2021
- Last updated
- 11 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartStart HS1 Defibrillator* Event Registry
- ClinicalTrials.gov ID
- NCT04840797
- Acronym / sponsor ID
- TC_ECR_HS1_2020_10819
- Conditions
- Sudden Cardiac Arrest
- Keywords
- AED, Post -Market, Cardiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Heartstream US LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Apr 2021 (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 Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.
Detailed description
The objective of this PMCF (Post Market Clinical Follow-up) prospective collection of post-event data registry is to confirm the safety and performance as expressed in the energy delivery by the HeartStart HS1 Defibrillator (HeartStart OnSite and Home models in North America) in the population for the device's intended use in reference to its commercial labeling, and in relationship to the type of pads attached to the device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Sudden Cardiac Arrest | – | Device: HeartStart HS1All subjects with suspected of a circulatory arrest of any cause. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anyone who is suspected of having a sudden cardiac arrest.
Key inclusion criteria (3 listed)
- Have been suspected of a circulatory arrest for any cause.
- Have had HeartStart HS1 Defibrillator with electrodes:
- Adult SMART Pads Cartridge [REF: M5071A], Infant/Child SMART Pads Cartridge (REF:M5072A) applied to their body and powered up with HS1 battery (Model M5070A), regardless of whether a defibrillation shock was delivered
Key exclusion criteria (3 listed)
- Subjects will be excluded if any of the following are present:
- AED or pad use other than the HeartStart HS1 Defibrillator with above referenced Philips electrode pads. Note: Use of a device other than the Philips HeartStart HS1 AED does not preclude enrollment if the AED or an Advanced Life Support defibrillator was used after the HeartStart HS1 AED.
- AED used for training purposes.
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 |
|---|---|---|
| HeartStart HS1Automated External Defibrillator | Device | Suspected Sudden Cardiac Arrest |
Primary outcome
Mean shock energy delivered in the pediatric population
Time frame: Up to 15 minutes during device placement
Mean of shock energy delivered, when the pediatric defibrillation pads were attached to the AED as intended for infants and children under 25 kilograms / 55 pounds or 0-8 years old.
Mean shock energy delivered in the adult population
Time frame: Up to 15 minutes during device placement
Mean of shock energy delivered, when the adult defibrillation pads were attached to the AED as intended for in children and adults over 25 kilograms / 55 pounds or greater than 8 years old.
The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement.
Time frame: Up to 15 minutes during device placement
Performance is defined by the sensitivity and specificity; positive predictive value and false positive rate will be reported for each rhythm category (as defined by device labeling).
Accurate detection of shockable rhythms and facilitation of shocks.
Time frame: Up to 15 minutes during device placement
The percentage of events where a shockable rhythm was identified by the device, the device advised a shock, and the device delivered a shock when the shock button was pressed.
Defibrillation success
Time frame: Up to 15 minutes during device placement
Defibrillation success and the number of shocks required for success.
12 secondary outcomes
Frequency and severity of unexpected adverse events
Time frame: Up to 15 minutes during device placement
Unanticipated adverse device effects (UADE)
Time frame: Up to 15 minutes during device placement
Median operating time intervals
Time frame: Up to 15 minutes during device placement
Routine self-test performance/Battery Insertion self-test performance
Time frame: Up to 15 minutes during device placement
Device arming after shock advisement.
Time frame: Up to 15 minutes during device placement
Energy delivered consistent with device labeling
Time frame: Up to 15 minutes during device placement
Pad replacement notification
Time frame: Up to 15 minutes during device placement
Shock button effectively pressed after shock advisement
Time frame: Up to 15 minutes during device placement
Indicators of battery status/depletion (device logged data)
Time frame: Up to 15 minutes during device placement
Aborted shocks because of low or high impedance
Time frame: Up to 15 minutes during device placement
CPR guidance initiated (i-button pushed)
Time frame: Up to 15 minutes during device placement
CPR activity
Time frame: Up to 15 minutes during device placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Gerrit Noordergraaf, MD PhD principal investigator
Philips Healthcare
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, 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chase Wennick (617-398-7347, chase.wennick@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean shock energy delivered in the pediatric population (time frame: Up to 15 minutes during device placement). The study lists 5 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 11 Aug 2026.