Benefits of µCor in Ambulatory Decompensated Heart Failure

Subjects meeting the inclusion/exclusion criteria will wear µCor for 90 days from the day of
fitting. 500 total patients will be enrolled. There will be an interim analysis when the
200th subject has finished the study in the study to assess for distribution of patients with
reduced and preserved LVEF.

Subjects will be fitted with µCor during hospital discharge or within a clinic visit that has
occurred within 10 days of a heart failure related hospitalization. The µCor fitting will
mark day 0 of the study. An LVEF measurement will be recorded during enrollment or within 30
days post enrollment if an LVEF measurement has not been recorded within 30 days prior to
enrollment. An investigator assessment will be performed during all clinic visits. The
assessment template is shown in Appendix A.

Subjects will be given a diary at enrollment that will ask them to rate their degree of
specific symptoms of heart failure such as shortness of breath and fatigue as well as mark
any heart failure related clinical events or medication changes that have occurred since the
last entry.

Study follow up visits will occur at day 30, day 60, and day 90. During follow up visits the
subjects will be asked about any heart failure related clinical events or change in symptoms
that have occurred since the last follow up. The subject will receive a study based weekly
phone call asking the subject about any recent heart failure related clinical events or
change in heart failure symptoms. During the weekly phone call the subject will be reminded
to fill out the daily diary. No phone calls will be given on the week where there is a study
follow up visit. There will be 9 total phone calls.

During the Day 90 visit, the subject will be given the option to continue wearing the µCor
for an additional 90 days. Furthermore, if the subject experienced a heart failure related
clinical event within the initial 90 days of wear, the subject will be given the option of
wearing the µCor for 30 days following the heart failure event. .If the subject chooses
additional wear time, weekly phone calls and monthly visits will be structured identical to
that of the main study period. The µCor will be returned at end of use.

There will be a follow up at six months and one year post enrollment to document mortality
data, heart failure related clinical events, and health care utilization data.

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.