Arrhythmias & electrophysiology
First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator
Authors' conclusion
This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF.
Study context
- Population
- Patients scheduled for an electrophysiology (EP) procedure in which VT/VF was expected to occur spontaneously or be induced
- Participants
- 18 eligible subjects
- Outcome
- Successful VT/VF termination with a single shock
Methodological detailsfirst-in-human, single-centre, group sequential design (Pocock alpha spending)
- First-in-human
- Single-centre
- Group sequential design (Pocock alpha spending)
Main finding
As reported in the abstract
- Exceeded primary endpoint performance goal (62%)
- 18 eligible subjects
- One-sided lower 97.4% exact confidence bound; performance goal 62%
- Group sequential design, Pocock alpha spending function
Observational data: associations, not effects.
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator. Europace. Published 13 July 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →