Trials / Recruiting
RecruitingNCT04840797
HeartStart HS1 Defibrillator* Event Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,400 (estimated)
- Sponsor
- Philips Clinical & Medical Affairs Global · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HeartStart HS1 | Automated External Defibrillator |
Timeline
- Start date
- 2021-02-25
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2021-04-12
- Last updated
- 2025-02-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04840797. Inclusion in this directory is not an endorsement.