Trials / Completed
CompletedNCT05490459
Jewel Electrophysiology (EP) Lab Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Element Science, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.
Detailed description
The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel, using a single transthoracic defibrillation shock to terminate life-threatening VT or VF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) | Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed. |
Timeline
- Start date
- 2018-11-27
- Primary completion
- 2021-10-07
- Completion
- 2024-04-17
- First posted
- 2022-08-05
- Last updated
- 2025-01-06
- Results posted
- 2025-01-06
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT05490459. Inclusion in this directory is not an endorsement.