Sudden Cardiac ArrestNCT05490459
Jewel Electrophysiology (EP) Lab Study
A study testing Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) in people with Sudden Cardiac Arrest, run by Element Science, Inc. at 1 site in Czechia.
Trial summary
Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Arrest
- What is being tested?
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Nov 2018to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.
Read the detailed description
The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel, using a single transthoracic defibrillation shock to terminate life-threatening VT or VF.
- Conditions
- Sudden Cardiac Arrest
- Being tested
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)Device
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Safety and Effectiveness Receives: Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Effectiveness of the Jewel
The count of participants with successful single shock terminations of life-threatening VT or VF. (The endpoint would be achieved if the lower confidence limit exceeds the performance goal of 62% using a one-sided exact lower 97.4% confidence bound at one of three testing points.)
Measured: Immediately following defibrillation with the study device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start27 Nov 2018
- Primary completion7 Oct 2021
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Element Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Petr Neužil, MD, PhD, FESC, Principal investigator, Nemocnice na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490459
- Sponsor's protocol ID
- PR-2038
- Status last verified
- May 2025
- First submitted
- 27 Jul 2022
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chovanec M, Petru J, Hala P, Kralovec S, Thakkar AB, Mathews K, Dinger M, Ullery S, Eapen ZJ, Kumar UN, Neuzil P. First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator. Europace. 2024 Jul 2;26(7):euae189. doi: 10.1093/europace/euae189.
PubMed 39001864
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jewel Electrophysiology (EP) Lab Study
- ClinicalTrials.gov ID
- NCT05490459
- Acronym / sponsor ID
- PR-2038
- Conditions
- Sudden Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Element Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.
Detailed description
The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel, using a single transthoracic defibrillation shock to terminate life-threatening VT or VF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)Safety and Effectiveness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment |
Primary outcome
Clinical Effectiveness of the Jewel
Time frame: Immediately following defibrillation with the study device.
The count of participants with successful single shock terminations of life-threatening VT or VF. (The endpoint would be achieved if the lower confidence limit exceeds the performance goal of 62% using a one-sided exact lower 97.4% confidence bound at one of three testing points.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39001864Chovanec M, Petru J, Hala P, Kralovec S, Thakkar AB, Mathews K, Dinger M, Ullery S, Eapen ZJ, Kumar UN, Neuzil P. First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator. Europace. 2024 Jul 2;26(7):euae189. doi: 10.1093/europace/euae189.
- EuropaceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Petr Neužil, MD, PhD, FESC principal investigator
Nemocnice na Homolce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) in people with Sudden Cardiac Arrest, run by Element Science, Inc. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Effectiveness of the Jewel (time frame: Immediately following defibrillation with the study device.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.