Clinical trial NCT05490459: Jewel Electrophysiology (EP) Lab Study
Official title: Jewel Electrophysiology (EP) Lab Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Arrest
Lead sponsor: Element Science, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Effectiveness of the Jewel
timeFrame: Immediately following defibrillation with the study device.
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Nemocnice Na Homolce Hospital
Study officials:
affiliation: Nemocnice na Homolce Hospital
name: Prof. Petr Neužil, MD, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.