Evaluating heart monitoring accuracy with a wearable device
Official title: Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
Run by Zoll Medical Corporation · NCT04292405 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing how well a wearable heart monitor works for people with heart failure by comparing its readings to another heart monitoring device.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Zoll Medical Corporation Industry-sponsored |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04292405 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with heart failure or a history of heart failure and an ejection fraction of 40% or less.
✕Probably not a fit
Patients with implanted left ventricular assist devices, pacemaker dependency, or those currently hospitalized may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the accuracy of cardiac acoustic biomarkers recorded by the Wearable Cardioverter Defibrillator (WCD) in comparison to data obtained from the AUDICOR AM acoustic cardiography recorder. It is a single-arm, prospective study that involves participants who have heart failure or a history of heart failure. The study will collect and analyze data from both devices simultaneously to determine the reliability of the WCD in monitoring heart conditions.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of heart monitoring for patients with heart failure, leading to better management of their condition.
How similar studies have gone: While this approach is innovative, similar studies evaluating cardiac monitoring devices have shown promising results in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * implanted left ventricular assist device * pacemaker dependency * currently hospitalized * atrial fibrillation on their last ECG or having an irregularly irregular pulse
Where it's running
-
MAYO Clinic
Rochester, Minnesota, United States Recruiting
Study contacts
- Study coordinator: Jennifer D Dean, MS
- Email: jdean@zoll.com
- Phone: 4129683333
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.