RecruitingNot Applicable

HeartStart HS1 Defibrillator* Event Registry

United States1,400 participantsStarted 2021-02-25

Plain-language summary

A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean shock energy delivered in the pediatric population

Timeframe: Up to 15 minutes during device placement

Mean shock energy delivered in the adult population

Timeframe: 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.

Timeframe: Up to 15 minutes during device placement

Accurate detection of shockable rhythms and facilitation of shocks.

Timeframe: Up to 15 minutes during device placement

Defibrillation success

Timeframe: Up to 15 minutes during device placement

Trial details

NCT IDNCT04840797

SponsorHeartstream US LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-12-31

Contact for this trial

Chase Wennick

617-398-7347 chase.wennick@philips.com

View on ClinicalTrials.gov More Sudden Cardiac Arrest trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean shock energy delivered in the pediatric population

Timeframe: Up to 15 minutes during device placement

Mean shock energy delivered in the adult population

Timeframe: 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.

Timeframe: Up to 15 minutes during device placement

Accurate detection of shockable rhythms and facilitation of shocks.

Timeframe: Up to 15 minutes during device placement

Defibrillation success

Timeframe: Up to 15 minutes during device placement