ClinicalTrials.gg
TerminatedNCT04292405ACABUpdated Oct 30, 2025

Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

An observational study in Heart Failure, sponsored by Zoll Medical Corporation. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-30.

Sponsored by Zoll Medical Corporation · Observational

Why this study was terminated
Unable to enroll suitable subjects
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Single arm, prospective, non significant risk device study to evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) compared with the CABs data simultaneously recorded by an acoustic cardiography recorder, the AUDICOR AM device.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's enrollment of 60 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Zoll Medical Corporation is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Primary Care, Heart Failure, and Cardiology

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • implanted left ventricular assist device
  • pacemaker dependency
  • currently hospitalized
  • atrial fibrillation on their last or having an irregularly irregular pulse
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Heart Failure Patients

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

    Device: Wearable Cardioverter Defibrillator

Interventions

  • DeviceWearable Cardioverter Defibrillator

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

    Also known as: AUDICOR AM

06

What researchers measure

Primary outcomes

  1. CABs comparison

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

    Time frame: 2 hours

07

Study locations

1 site
  • MAYO Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Sep 2025, 68 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2020
First posted
Mar 3, 2020
StartActual
Jan 23, 2020
Primary completionActual
Sep 30, 2025
CompletionActual
Sep 30, 2025
Last update
Oct 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04292405
Responsible party
Sponsor
First posted
Mar 3, 2020
Start date
Jan 23, 2020
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Oct 30, 2025

Study contacts

Mike Osz
study director · Director, Clinical Operations, ZOLL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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