Registry for HeartStart HS1 Defibrillator performance and safety
HeartStart HS1 Defibrillator* Event Registry
This study looks at how well the HeartStart HS1 Defibrillator works and keeps people safe after they have a suspected heart attack.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04840797 on ClinicalTrials.gov |
What this trial studies
This observational study collects post-event data on the HeartStart HS1 Defibrillator to evaluate its safety and performance in real-world scenarios. It focuses on individuals who have experienced a suspected circulatory arrest and have had the HeartStart HS1 device applied. The study aims to confirm the effectiveness of the device as per its commercial labeling and assess the impact of different electrode pads used with the defibrillator. Data will be gathered prospectively to ensure comprehensive analysis of outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have experienced a suspected circulatory arrest and have had the HeartStart HS1 Defibrillator applied.
Not a fit: Patients who used a different defibrillator or training devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the HeartStart HS1 Defibrillator's effectiveness, potentially leading to improved survival rates in sudden cardiac arrest patients.
How similar studies have performed: Other studies have shown success in evaluating the performance of defibrillators, making this approach both relevant and necessary for ongoing safety assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- Philips — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Gerrit Noordergraaf, MD PhD — Philips Healthcare
- Study coordinator: Chase Wennick
- Email: chase.wennick@philips.com
- Phone: 617-398-7347
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.