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Wearable patch shocks heart back to rhythm in lab study

NCT ID NCT05490459

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

18 people

The number who actually took part.

Started

Nov 2018

Finished

Apr 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Nemocnice Na Homolce Hospital

    Prague, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.