Heart Failure
Conditions
Brief summary
A prospective, validation study to evaluate the data accuracy of heart sounds recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD). These data will be compared with the heart sounds data recorded by an FDA-cleared device AUDICOR AM device.
Detailed description
To conduct a prospective, validation study to evaluate the data accuracy of heart sounds recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD). To show equivalence, these data will be compared with the heart sounds data recorded by an FDA-cleared AUDCIOR AM device . The study will enroll a minimum of 27 and a maximum of 35 subjects. Participants will be adult patients (age ≥ 18 years) with at least seven patients over the age of 40 years. In addition, at least five patients with a history of heart failure will be included. First, participants will wear the AUDICOR-AM device for 15 minutes while sitting quietly. Then, the AUDICOR device will be removed and the participants will wear the WCD for 15 minutes while sitting quietly. Next, while wearing the WCD, participants will perform various activities of daily living, including at least 6 hours of overnight wear. Finally, the WCD will be removed and the participants will wear the AUDICOR again for 15 minutes while sitting quietly. This is a single center, prospective, observational study. This is a non-significant risk device study as all biological study parameters will be measured noninvasively with the WCD defibrillation capability disabled. In addition, the study device will not be used as a replacement for regularly prescribed therapies or diagnostics.
Interventions
DEVICEAUDICOR then LifeVest then AUDICOR
Wearable Cardioverter Defibrillator to record acoustic cardiograph signals.
Sponsors
Zoll Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Each subject first wears the AUDICOR-AM device for 15 minutes while sitting. Then the AUDICOR device is removed and the subject wears the WCD for 12-16 hours. After the WCD wear period, the WCD device is removed and the subject wears the AUDICOR device again for 15 minutes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female volunteers who are able to fit in the WCD garment (26 to 56 inches measured circumferentially at the level of the xiphoid process). * Included in this group are at least five healthy subjects with a self-reported history of heart failure. * The subject must be 18 years of age or older on the day of screening, with at least 7 subjects 40 years of age or older on the day of screening.
Exclusion criteria
* Mental, visual, physical, literacy, and auditory limitations that prevent interaction with the WCD equipment. * Any acute medical conditions that prevent the following maneuvers: lying on back, lying on the right and left side, standing, sitting, and/ or leaning forward when sitting. * Any self-reported shortness of breath, fatigue, swelling of feet, ankles, or legs, and/or chest pain * Employees or family members of the sponsor. * Unable or unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System. | 15 minutes of sitting for each group of measurements (Audicor device, then LifeVest, then Audicor device again). | Equivalence of the LifeVest device to the AUDICOR device was established by comparing the electromechanical activation time (EMAT) data of each device, collected during quiet sitting. The outcome was reported as the difference in EMAT measured by the LifeVest and AUDICOR device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AUDICOR AM Device, Then LifeVest, Then AUDICOR AM Device Assigned to wear the AUDICOR device first, then the WCD, and finally the AUDICOR device again. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | AUDICOR AM Device, Then LifeVest, Then AUDICOR AM Device |
|---|---|
| Age, Continuous | 47.1 Years STANDARD_DEVIATION 15.9 |
| Body-mass index | 29.1 kg/m^2 STANDARD_DEVIATION 4.5 |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System.
Equivalence of the LifeVest device to the AUDICOR device was established by comparing the electromechanical activation time (EMAT) data of each device, collected during quiet sitting. The outcome was reported as the difference in EMAT measured by the LifeVest and AUDICOR device.
Time frame: 15 minutes of sitting for each group of measurements (Audicor device, then LifeVest, then Audicor device again).
Population: All subjects participating in the study were adult patients (age ≥ 18 years).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AUDICOR AM Device (First) Wear | To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System. | 95.88 ms | Standard Deviation 17.5 |
| LifeVest Wear | To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System. | 96.98 ms | Standard Deviation 15.04 |
| AUDICOR AM Device (Second) Wear | To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System. | 98.25 ms | Standard Deviation 19.11 |
Comparison: First, the difference in EMAT between the LifeVest and AUDICOR device (first wear) was calculated for each subject. Then the mean and standard deviation of the differences in EMAT were calculated. The 2 devices were considered equivalent if the 90% confidence interval for mean difference in EMAT was within the pre-specified margin of \[-12, 12\] ms.p-value: <0.00190% CI: [-2.89, 4.69]two one-sided test (TOST)