Benefits of Microcor in Ambulatory Decompensated Heart Failure (BMAD-TX)

ZOLL Medical

Status

Completed

Conditions

Heart Failure

Treatments

Device: μCor

Study type

Interventional

Funder types

Industry

Identifiers

NCT04096040

90D0202

Details and patient eligibility

About

To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

Full description

Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days.

During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events.

The subject will be given a daily diary to track symptoms, 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.

The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators.

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.

Enrollment

265 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
4.1.3 Subjects 21 years of age or older on the day of screening.

Exclusion criteria

4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
4.2.4 Subjects anticipated to start dialysis within 90 days.
4.2.5 Subjects currently implanted with an subcutaneous implantable cardio defibrillator (S-ICD) system.
4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
4.2.7 Subjects who are unable to participate in all follow up visits.
4.2.8 Subjects participating in research other than a registry at the time of enrollment.
4.2.9 Subjects currently implanted with a Left Ventricular Assist Device (LVAD).
4.2.10 Subjects with self-reported pregnancy.
4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.