Trial Outcomes & Findings for Jewel Electrophysiology (EP) Lab Study (NCT NCT05490459)

NCT ID: NCT05490459

Last Updated: 2025-01-06

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.)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Immediately following defibrillation with the study device.
• Results posted on: 2025-01-06

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=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index (kg/cm^2)	28.3 kg/cm^2 n=5 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 events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Element Science, Inc.

Phone: 4158726500

Email: zubin@elementsci.com

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