Sudden Cardiac Arrest
Conditions
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.
Interventions
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.
Sponsors
Element Science, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Effectiveness of the Jewel | 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.) |
Countries
Czechia
Contacts
PRINCIPAL_INVESTIGATORProf. Petr Neužil, MD, PhD, FESC
Nemocnice na Homolce Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 63.8 years |
| Body Mass Index (kg/cm^2) | 28.3 kg/cm^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
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.)
Time frame: Immediately following defibrillation with the study device.
Population: Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Clinical Effectiveness of the Jewel | 16 Participants |