NCT04096040

Benefits of Microcor in Ambulatory Decompensated Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	μCor	μCor consists of the following components: A) Patch B) Sensor C) Charger D) Data transmission device (Gateway) E) Server Once activated, the wearable Sensor automatically acquires ECG, RF readings, heart rate, respiration rate, activity, and posture measurements.

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-06-30
• Completion: 2023-10-30
• First posted: 2019-09-19
• Last updated: 2025-01-08
• Results posted: 2024-10-09

Locations

83 sites across 4 countries: United States, Austria, France, Germany

Regulatory

• FDA-regulated device study