Sudden Cardiac ArrestNCT04250857
HeartStart FRx Defibrillator Event Registry
An observational study of Sudden Cardiac Arrest, run by Heartstream US LLC at 1 site in United States.
Trial summary
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sudden Cardiac Arrest
- What is being tested?
- HeartStart FRX
- Type of treatment
- Medical device
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 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
- Child, Adult, Older adult
Study population: Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.
Who may be able to join
- Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
- Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered
Who cannot join
- AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
- 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
Monroeville, Pennsylvania, 15146
Barb Fink, 7247087048, barb.fink@philips.com
Gerrit Noordergraaf, MD
About this study
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.
- Conditions
- Sudden Cardiac Arrest
- Being tested
- HeartStart FRX
- 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 FRXDevice
Automated External Defibrillator
| Study group | Role | What they receive |
|---|---|---|
| Suspected Sudden Cardiac Arrest | All subject with suspected of a circulatory arrest for any cause. Receives: Device: HeartStart FRX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm accuracy
Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Measured: Up to 15 minutes after device placement
Shock Delivery
Percentage of events where a shock was delivered when indicated.
Measured: 1 day
Unexpected adverse events.
Frequency and severity of unexpected adverse events.
Measured: 1 day
Unanticipated adverse device effects (UADE)
Unanticipated adverse device effects (UADE)
Measured: 1 day
Secondary outcomes (5)
Time Intervals
Measurements of device performance time intervals.
Measured: 1 day
Device Preparation
Percentage of events where the device prepared to shock.
Measured: 1 day
Shock Energy Delivered
The amount of shock energy delivered as measured in joules with each shock.
Measured: 1 day
Pad Replacement
Frequency of pad replacement.
Measured: 1 day
User
Frequency of user pressing the shock button.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start4 Nov 2019
- 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
- Cohort
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250857
- Sponsor's protocol ID
- MATC-ECR-Registry-2018-10295
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2019
- 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 FRx Defibrillator Event Registry
- ClinicalTrials.gov ID
- NCT04250857
- Acronym / sponsor ID
- MATC-ECR-Registry-2018-10295
- Conditions
- Sudden Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Heartstream US LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 31 Jan 2020 (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.
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Sudden Cardiac Arrest | – | Device: HeartStart FRXAll subject with suspected of a circulatory arrest for any cause. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.
Key inclusion criteria (2 listed)
- Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
- Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered
Key exclusion criteria (2 listed)
- AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
- 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 FRXAutomated External Defibrillator | Device | Suspected Sudden Cardiac Arrest |
Primary outcome
Algorithm accuracy
Time frame: Up to 15 minutes after device placement
Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Shock Delivery
Time frame: 1 day
Percentage of events where a shock was delivered when indicated.
Unexpected adverse events.
Time frame: 1 day
Frequency and severity of unexpected adverse events.
Unanticipated adverse device effects (UADE)
Time frame: 1 day
Unanticipated adverse device effects (UADE)
5 secondary outcomes
Time Intervals
Time frame: 1 day
Device Preparation
Time frame: 1 day
Shock Energy Delivered
Time frame: 1 day
Pad Replacement
Time frame: 1 day
User
Time frame: 1 day
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
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.
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 2 inclusion and 2 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 Barb Fink (724-708-7048, barb.fink@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algorithm accuracy (time frame: Up to 15 minutes after device placement). The study lists 4 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.