NCT07256678

Brief Summary

The objective of this PAS is to demonstrate the continued safety and clinical effectiveness of the Jewel P-WCD.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,330

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Jan 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2029

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

3.8 years

First QC Date

November 20, 2025

Last Update Submit

November 20, 2025

Conditions

Jewel-P WCD

Outcome Measures

Primary Outcomes (1)

  • Percent of VT/VF events successfully detected by the Jewel P-WCD

    From enrollment to the end of treatment at approximately 90 days

Study Arms (1)

This study is an observational registry study of the Jewel P-WCD in post-market use

Other: This study is an observational registry study of the Jewel P-WCD in post-market useOther: Jewel

Interventions

This study is an observational registry study of the Jewel P-WCD in post-market useOTHER

This study is an observational registry study of the Jewel P-WCD in post-market use

This study is an observational registry study of the Jewel P-WCD in post-market use
JewelOTHER

This study is an observational registry study of the Jewel P-WCD in post-market use

This study is an observational registry study of the Jewel P-WCD in post-market use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient population who are at elevated risk of Sudden Cardiac Arrest (SAC) while they wait for permanent diagnosis.

You may qualify if:

  • N/A - registry will collect data already obtained commercially from patients prescribed the Jewel P-WCD.

You may not qualify if:

  • N/A - registry will collect data already obtained through commercial consent from patients prescribed the Jewel P-WCD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

VP, Regulatory Affairs and Quality

CONTACT

408-212-1516vis@elementsci.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share