Jewel Electrophysiology (EP) Lab Study
Primary Purpose
Sudden Cardiac Arrest
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Sponsored by
About this trial
This is an interventional treatment trial for Sudden Cardiac Arrest
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Nemocnice Na Homolce Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Outcomes
Primary Outcome Measures
Clinical Effectiveness of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Percent of successful terminations of life-threatening VT or VF
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05490459
Brief Title
Jewel Electrophysiology (EP) Lab Study
Official Title
Jewel Electrophysiology (EP) Lab Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Element Science, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Intervention Type
Device
Intervention Name(s)
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Intervention Description
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.
Primary Outcome Measure Information:
Title
Clinical Effectiveness of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Description
Percent of successful terminations of life-threatening VT or VF
Time Frame
Immediately following defibrillation with the study device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Petr Neužil, MD, PhD, FESC
Organizational Affiliation
Nemocnice na Homolce Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemocnice Na Homolce Hospital
City
Prague
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
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Jewel Electrophysiology (EP) Lab Study
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