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

NCT02825966 | Completed Results

• 1 other identifier: 90D0153
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (1)

AUDICOR then LifeVest then AUDICOR

OTHER

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

Interventions

AUDICOR then LifeVest then AUDICOR DEVICE

Wearable Cardioverter Defibrillator to record acoustic cardiograph signals.

AUDICOR then LifeVest then AUDICOR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (1)

MedPace Phase 1 Clinic

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: ZOLL

mosz@zoll.com

4129683333

Study Officials

• Steve Szymkiewicz, MD

  VP Medical Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 7, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)