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BMAD-TX

Trial Overview

Official Title

Benefits of Microcor in Ambulatory Decompensated Heart Failure

Study Purpose

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.

Diagnosis

Heart Failure

Eligibility

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 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 an LVAD.
• 4.2.10 Subjects with self-reported pregnancy.
• 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Intervention

  • 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.
Key Participation Requirements
Trial Location(s)
Gender
Male or Female
Age
21 Years and older
Phase
Not Applicable
Methodist Health System Trial Code
NCT04096040
Related Specialties