Registry for the HeartStart FRx Defibrillator's performance in cardiac arrest cases
HeartStart FRx Defibrillator Event Registry
Philips Clinical & Medical Affairs Global · NCT04250857
This study is collecting information on how well the HeartStart FRx defibrillator works during cardiac arrests to see if it lives up to its promises.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global (industry) |
| Locations | 1 site (Monroeville, Pennsylvania) |
| Trial ID | NCT04250857 on ClinicalTrials.gov |
What this trial studies
This observational registry collects post-event data on the performance of the HeartStart FRx Automated External Defibrillator (AED) used during suspected circulatory arrests. It includes participants who had the device applied, regardless of whether a shock was delivered, ensuring a comprehensive evaluation of the device's safety and clinical performance. The study employs safeguards to minimize selection bias by enrolling all eligible subjects who had the AED pads placed. The registry aims to verify the device's claims as outlined in the Device Manual.
Who should consider this trial
Good fit: Ideal candidates for this registry are individuals suspected of experiencing a circulatory arrest who had the HeartStart FRx AED applied.
Not a fit: Patients who used a different AED or those who were involved in training scenarios will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of the HeartStart FRx AED's effectiveness, potentially improving outcomes for patients experiencing sudden cardiac arrest.
How similar studies have performed: While this registry focuses on a specific device, similar observational studies have successfully evaluated AED performance in the past, indicating a precedent for this type of research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II * AED used for training purposes.
Where this trial is running
Monroeville, Pennsylvania
- Philips — Monroeville, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Barb Fink
- Email: barb.fink@philips.com
- Phone: 724-708-7048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sudden Cardiac Arrest