Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

Back to homepage
myLoyola

NCT03476187

Benefits of µCor in Ambulatory Decompensated Heart Failure

Official Title:

Benefits of µCor in Ambulatory Decompensated Heart Failure

Summary

Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days. During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of µCor wear, and any health care utilization since the end of µCor wear.

Eligibility

Inclusion Criteria:

* Subjects either hospitalized for decompensated systolic, diastolic, or combined heart failure or subjects presenting at an outpatient clinic with a history of hospital discharge for decompensated systolic, diastolic, or combined heart failure within the previous 10 days.
* All subjects must be 21 years of age or older on the day of screening.

Exclusion Criteria:

* Subjects who are wearing the wearable cardioverter defibrillator (WCD)
* Subjects not expected to survive one year from enrollment from non-cardiac disease.
* Subjects with skin allergy or sensitivity to medical adhesives.
* Subjects anticipated to start dialysis within 90 days.
* Subjects currently implanted with an S-ICD system.
* Subjects whose primary diagnosis on hospital admission was Acute Coronary Syndrome (ACS) STEMI/NSTEMI rather than heart failure exacerbation.
* Subjects who are unable to participate in all follow up visits.
* Subjects participating in any other research at time of enrollment.
* Subjects currently implanted with an LVAD.

Disease(s) and\or Condition(s)

Heart Failure

Primary Purpose
  • DIAGNOSTIC
Intervention/Treatment
    • Type: DEVICE
    • Name: µCor
    • Description: Monitor with µCor
    • Arm Group Labels: µCor wearers
Sponsor
  • Zoll Medical Corporation