Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

NCT04292405 | Terminated FDA Device

• 1 other identifier: 90d0214
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• CABs comparison

  Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared

  2 hours

Study Arms (1)

Heart Failure Patients

Simultaneous recordings of cardiac acoustic biomarkers (CABs) by the Wearable Cardioverter Defibrillator and the AUDICOR AM

Device: Wearable Cardioverter Defibrillator

Interventions

Wearable Cardioverter Defibrillator DEVICE

Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.

Also known as: AUDICOR AM

Heart Failure Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care, Heart Failure, and Cardiology

You may qualify if:

• years of age or older
• heart failure or a history of heart failure
• ischemic or non-ischemic cardiomyopathy
• ejection Fraction less than or equal to 40% as measured within the last 6 months

You may not qualify if:

• implanted left ventricular assist device
• pacemaker dependency
• currently hospitalized
• atrial fibrillation on their last ECG or having an irregularly irregular pulse

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (1)

MAYO Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mike Osz

  Director, Clinical Operations, ZOLL

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: January 23, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)