N/A
Completed N=18
Jewel Electrophysiology (EP) Lab Study
Source: ClinicalTrials.gov NCT05490459 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Clinical Effectiveness of the Jewel — 16 Participants
Summary
Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Effectiveness of the Jewel |
16 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects of both genders of at least 18 years of age.
- Subjects who are scheduled for a standard EP clinical procedure where fast VT or VF may spontaneously occur or may be induced.
Exclusion Criteria
- Subjects who may require sterile access to the right upper pectoral or lower left torso regions during the planned EP procedure.
- Subjects who have taken amiodarone in the past 3 months.
- Subjects with an existing unipolar pacemaker.
- Subjects who exhibit a left ventricular ejection fraction (LVEF) less than 20% (as assessed by techniques such as echocardiography, magnetic resonance imaging, or radionuclide angiography) within the last 6 months.
- Subjects who have been diagnosed with heart failure (Class IV) or experienced an acute heart failure exacerbation within the previous 30 days.
- Subjects who exhibit unstable angina.
- Subjects with atrial fibrillation with contraindication to anticoagulation or improper anticoagulation management.
- Subjects who are participating in an investigational study of a drug, biologic, or device not currently approved for marketing.
- Subjects who are allergic to or have had a known adverse reaction to medical adhesives.
- Subjects who have active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the study device is applied.
- Subjects with a lower abdomen circumference of less than 68.5 cm or greater than 142 cm.
- Females who are pregnant or breastfeeding, or planning to be pregnant in the next 12 months.
- Subjects who cannot provide or have diminished capacity to provide informed consent.
- Any condition that an Investigator believes would interfere with the intent of the study or is not in the best interest of the patient.
- Any patient that according to the Declaration of Helsinki is unsuitable for enrollment.
Data sourced from ClinicalTrials.gov (NCT05490459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.