Wearable patch shocks heart back to rhythm in lab study
NCT ID NCT05490459
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a wearable defibrillator patch (the Jewel) in 18 adults who were already scheduled for a heart procedure. The patch was used to deliver a shock to stop dangerous heart rhythms that could lead to sudden cardiac arrest. The goal was to see how often the patch could successfully stop these rhythms with a single shock.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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18 people
The number who actually took part.
- Started
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Nov 2018
- Finished
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Apr 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects of both genders of at least 18 years of age. 2. Subjects who are scheduled for a standard EP clinical procedure where fast VT or VF may spontaneously occur or may be induced. Exclusion Criteria: 1. Subjects who may require sterile access to the right upper pectoral or lower left torso regions during the planned EP procedure. 2. Subjects who have taken amiodarone in the past 3 months. 3. Subjects with an existing unipolar pacemaker. 4. 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. 5. Subjects who have been diagnosed with heart failure (Class IV) or experienced an acute heart failure exacerbation within the previous 30 days. 6. Subjects who exhibit unstable angina. 7. Subjects with atrial fibrillation with contraindication to anticoagulation or improper anticoagulation management. 8. Subjects who are participating in an investigational study of a drug, biologic, or device not currently approved for marketing. 9. Subjects who are allergic to or have had a known adverse reaction to medical adhesives. 10. Subjects who have active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the study device is applied. 11. Subjects with a lower abdomen circumference of less than 68.5 cm or greater than 142 cm. 12. Females who are pregnant or breastfeeding, or planning to be pregnant in the next 12 months. 13. Subjects who cannot provide or have diminished capacity to provide informed consent. 14. Any condition that an Investigator believes would interfere with the intent of the study or is not in the best interest of the patient. 15. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nemocnice Na Homolce Hospital
Prague, Czechia
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Other studies related to the condition(s) this trial covers.
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