Trial Outcomes & Findings for Jewel Electrophysiology (EP) Lab Study (NCT NCT05490459)
NCT ID: NCT05490459
Last Updated: 2026-04-27
Results Overview
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.)
COMPLETED
NA
18 participants
Immediately following defibrillation with the study device.
2026-04-27
Participant Flow
Participant milestones
| Measure |
Treatment
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Jewel Electrophysiology (EP) Lab Study
Baseline characteristics by cohort
| Measure |
Treatment
n=18 Participants
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.
|
|---|---|
|
Age, Continuous
|
63.8 years
n=226 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=226 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=226 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=226 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=226 Participants
|
|
Body Mass Index (kg/cm^2)
|
28.3 kg/cm^2
n=226 Participants
|
PRIMARY outcome
Timeframe: Immediately following defibrillation with the study device.Population: Treatment
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.)
Outcome measures
| Measure |
Treatment
n=18 Participants
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.
|
|---|---|
|
Clinical Effectiveness of the Jewel
|
16 Participants
|
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Zubin Eapen, MD; Michael McSweeney
Element Science, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the clinical trial or their parts shall not be published by Provider, Investigator, or other persons participating in the clinical trial shall not be disclosed to the general public without prior written consent of Sponsor. The Sponsor shall not refuses to grant consent without a reasonable cause.
- Publication restrictions are in place
Restriction type: OTHER