Benefits of µCor in Ambulatory Decompensated Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:1/19/2019
Start Date:June 25, 2018
End Date:March 2022
Contact:Mike A. Osz, B.Sc. (Hons)
Email:mosz@zoll.com
Phone:+1-412-968-3472

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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.

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.
We found this trial at
22
sites
McKinney, Texas 75069
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Amarillo, Texas 79106
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Bradenton, Florida 34209
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3050 Orchard Park Road
Buffalo, New York 14215
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Chicago, Illinois 60644
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Columbia, South Carolina 29203
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Delray Beach, Florida 33446
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Erie, Pennsylvania 16550
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5100 Gateway Center
Flint, Michigan 48507
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Fort Lauderdale, Florida 33334
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Fort Worth, Texas 76104
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Jacksonville, Florida 32207
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2111 Southwest 20th Place
Ocala, Florida 34471
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Oklahoma City, Oklahoma 73190
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Richmond, Virginia 23225
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Richmond, Virginia 23294
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Saint Petersburg, Florida 33709
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Yardley, Pennsylvania 19067
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