Trial Outcomes & Findings for The Jewel IDE Study (NCT NCT05201495)

Results Overview

Inappropriate shocks no more than 2.0 inappropriate shocks per 100 patient-months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

322 participants

Primary outcome timeframe

Prescription Period during which each patient wore the Jewel up to 180 days.

Results posted on

2026-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) 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.
Overall Study STARTED	322
Overall Study COMPLETED	314
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Jewel IDE Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Arm n=314 Participants Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in adult subjects aged 18 years and above at high risk for Sudden Cardiac Arrest, who were not candidates for or who refused an implanted cardioverter defibrillator.
Age, Continuous	57.8 years STANDARD_DEVIATION 13.5 • n=226 Participants
Sex: Female, Male Female	94 Participants n=226 Participants
Sex: Female, Male Male	220 Participants n=226 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=226 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	302 Participants n=226 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=226 Participants
Body Mass Index	30.0 kg/m2 STANDARD_DEVIATION 6.8 • n=226 Participants

PRIMARY outcome

Timeframe: Prescription Period during which each patient wore the Jewel up to 180 days.

Population: Of the 314 total patients completed, the primary analysis population was comprised of the 300 subjects who completed the study and had available device data contributing to analyzable wear time.

Inappropriate shocks no more than 2.0 inappropriate shocks per 100 patient-months.

Outcome measures

Outcome measures
Measure	Study Arm n=300 Participants Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in adult subjects aged 18 years and above at high risk for Sudden Cardiac Arrest, who were not candidates for or who refused an implanted cardioverter defibrillator.
Inappropriate Shock Rate	0.333 inappropriate shocks per 100 pt-months

PRIMARY outcome

Timeframe: Prescription Period during which each patient wore the Jewel up to 180 days.

Rate of subjects experiencing clinically significant cutaneous Adverse Device Effects of \< 15%

Outcome measures

Outcome measures
Measure	Study Arm n=314 Participants Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in adult subjects aged 18 years and above at high risk for Sudden Cardiac Arrest, who were not candidates for or who refused an implanted cardioverter defibrillator.
Cutaneous Adverse Device Effects	2.23 percentage of participants

Adverse Events

Study Arm

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Arm n=314 participants at risk Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in adult subjects aged 18 years and above at high risk for Sudden Cardiac Arrest, who were not candidates for or who refused an implanted cardioverter defibrillator.
Skin and subcutaneous tissue disorders Skin irritation	15.6% 49/314 • Number of events 51 • Prescription Period during which each patient wore the Jewel up to 180 days Adverse Events (AEs) defined as any untoward medical occurrence in a subject during the study that in the opinion of the investigator was at least potentially related to use of the Jewel system.

Additional Information

Zubin Eapen, MD; Michael McSweeney

Element Science, Inc.

Phone: (415) 872-6500; (408) 596-4531

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER