Status:
COMPLETED
Benefits of Microcor in Ambulatory Decompensated Heart Failure
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 visi...
Eligibility Criteria
Inclusion
- 1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
- 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
- 1.3 Subjects 21 years of age or older on the day of screening.
Exclusion
- 2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
- 2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
- 2.3 Subjects with skin allergy or sensitivity to medical adhesives.
- 2.4 Subjects anticipated to start dialysis within 90 days.
- 2.5 Subjects currently implanted with an subcutaneous implantable cardio defibrillator (S-ICD) system.
- 2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
- 2.7 Subjects who are unable to participate in all follow up visits.
- 2.8 Subjects participating in research other than a registry at the time of enrollment.
- 2.9 Subjects currently implanted with a Left Ventricular Assist Device (LVAD).
- 2.10 Subjects with self-reported pregnancy.
- 2.11 Subjects currently being actively managed with any device based remote HF monitoring.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT04096040
Start Date
November 1 2019
End Date
October 30 2023
Last Update
January 8 2025
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