Evaluating heart monitoring accuracy with a wearable device
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zoll Medical Corporation Industry-sponsored |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04292405 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with implanted left ventricular assist devices, pacemaker dependency, or those currently hospitalized may not benefit from this study.
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 performed: While this approach is innovative, similar studies evaluating cardiac monitoring devices have shown promising results in the past.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- MAYO Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer D Dean, MS
- Email: jdean@zoll.com
- Phone: 4129683333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.