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NCT05490459

Jewel Electrophysiology (EP) Lab Study

Completed NA Results posted Last updated 6 January 2025
What this trial tests

NA trial testing Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) in Sudden Cardiac Arrest in 18 participants. Completed in 17 April 2024.

Timeline
27 November 2018
Primary endpoint
7 October 2021
17 April 2024

Quick facts

Lead sponsorElement Science, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date27 November 2018
Primary completion7 October 2021
Estimated completion17 April 2024
Sites1 location across Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Element Science, Inc.

Who can join

18 and older, any sex, with Sudden Cardiac Arrest. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Effectiveness of the Jewel Primary · Immediately following defibrillation with the study device.

The count of participants with successful single shock terminations of life-threatening VT or VF. (The endpoint would be achieved if the lower confidence limit exceeds the performance goal of 62% using a one-sided exact lower 97.4% confidence bound at one of three testing points.)

GroupValue95% CI
Treatment16

Sponsor's own description

Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator.
    Chovanec M, Petrů J, Hála P, Kralovec S, et al · · 2024 · cited 2× · PMID 39001864 · DOI 10.1093/europace/euae189

Verify or expand the search:

Other trials of Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Trials testing the same drug.

Other recruiting trials for Sudden Cardiac Arrest

Currently open trials in the same condition.

Other Element Science, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05490459.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing