Clinical trial NCT02825966: Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study
Official title: Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD): Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System.
timeFrame: 15 minutes of sitting for each group of measurements (Audicor device, then LifeVest, then Audicor device again).
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: MedPace Phase 1 Clinic
state: Ohio
Study officials:
affiliation: VP Medical Affairs
name: Steve Szymkiewicz, MD
role: STUDY_DIRECTOR
References: