Heart FailureACABNCT04292405
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
An observational study of Heart Failure, run by Zoll Medical Corporation at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Wearable Cardioverter Defibrillator
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Primary Care, Heart Failure, and Cardiology
Who may be able to join
- 18 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
Who cannot join
- implanted left ventricular assist device
- pacemaker dependency
- currently hospitalized
- atrial fibrillation on their last ECG or having an irregularly irregular pulse
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Wearable Cardioverter Defibrillator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Cardioverter DefibrillatorDevice
Also called AUDICOR AM
Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Patients | Simultaneous recordings of cardiac acoustic biomarkers (CABs) by the Wearable Cardioverter Defibrillator and the AUDICOR AM Receives: Device: Wearable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
CABs comparison
Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start23 Jan 2020
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Why it stopped: Unable to enroll suitable subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Osz, Study director, Director, Clinical Operations, ZOLL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292405
- Sponsor's protocol ID
- 90d0214
- Acronym
- ACAB
- Status last verified
- Oct 2025
- First submitted
- 28 Feb 2020
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
- ClinicalTrials.gov ID
- NCT04292405
- Acronym / sponsor ID
- ACAB / 90d0214
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to enroll suitable subjects
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients | – | Device: Wearable Cardioverter DefibrillatorSimultaneous recordings of cardiac acoustic biomarkers (CABs) by the Wearable Cardioverter Defibrillator and the AUDICOR AM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary Care, Heart Failure, and Cardiology
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (4 listed)
- implanted left ventricular assist device
- pacemaker dependency
- currently hospitalized
- atrial fibrillation on their last ECG or having an irregularly irregular pulse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Cardioverter DefibrillatorAlso: AUDICOR AMUse of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings. | Device | Heart Failure Patients |
Primary outcome
CABs comparison
Time frame: 2 hours
Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared
Results and safety
The study was stopped early (reason given: Unable to enroll suitable subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Osz study director
Director, Clinical Operations, ZOLL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Zoll Medical Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to enroll suitable subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CABs comparison (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.