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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: AUDICOR then LifeVest then AUDICOR

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • MedPace Phase 1 Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AUDICOR then LifeVest then AUDICOR; 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.	Device: AUDICOR then LifeVest then AUDICOR; Wearable Cardioverter Defibrillator to record acoustic cardiograph signals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 minutes of sitting for each group of measurements (Audicor device, then LifeVest, then Audicor device again).

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Steve Szymkiewicz, MD, VP Medical Affairs

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 90D0153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No