Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study

ZOLL Medical

Status: Completed

Conditions: Heart Failure

Treatments: Device: AUDICOR then LifeVest then AUDICOR

Study type: Interventional

Funder types: Industry

Identifiers

NCT02825966

90D0153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

AUDICOR then LifeVest then AUDICOR

Other group

Description:

First, assigned to wear AUDICOR device for 15 minutes. Then assigned to wear the WCD, including 6 hours of overnight wear. Total anticipated wear time with WCD is 12-16 hours. Finally, assigned to wear the AUDICOR device for another 15 minutes after finishing the WCD wear.

Treatment:

Device: AUDICOR then LifeVest then AUDICOR