Jewel Electrophysiology (EP) Lab Study

Sudden Cardiac Arrest Clinical Trial

Official title:

Jewel Electrophysiology (EP) Lab Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05490459
• Other study ID #: PR-2038
• Status: Completed
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: April 17, 2024

Study information

• Verified date: June 2024
• Source: Element Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.

Description:

The objective of this study is to demonstrate the safety and clinical effectiveness of the Jewel EP Lab System in terminating life-threatening VT or VF with a single transthoracic defibrillation shock.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 17, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Arrest

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Czechia	Nemocnice Na Homolce Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Element Science, Inc.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Effectiveness of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)	Percent of successful terminations of life-threatening VT or VF	Immediately following defibrillation with the study device