A Study to Evaluate the Accuracy of Cardiac Acoustic Biomarkers by the Wearable Cardioverter Defibrillator

Overview

About this study

The purpose of this study is to evaluate the data accuracy of the cardiac acoustic biomarkers (CABs) recorded the FDA-approved LifeVest® Wearable Cardioverter Defibrillator (WCD). To show accuracy, these data will be compared with CABs data simultaneously recorded by the AUDICOR® AM device, a FDA cleared, acoustic cardiography recorder.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subjects must be 18 years of age or older on the day of screening.
  • Subjects with heart failure or history of heart failure.
  • Subjects with ischemic or non-ischemic cardiomyopathy.
  • Subjects with an ejection fraction ≤ 40%, measured within the last 6 months from screening for the study.

Exclusion Criteria:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bruce Johnson, Ph.D.

Open for enrollment

Contact information:

Briana Ziegler

(507)255-7125

Ziegler.Briana@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available