Status:
COMPLETED
Benefits of µCor in Ambulatory Decompensated Heart Failure
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT03476187
Start Date
August 17 2018
End Date
April 9 2024
Last Update
January 8 2025
Active Locations (61)
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1
Mobile Heart Specialists, PC
Mobile, Alabama, United States, 36608
2
University Hospital
Mobile, Alabama, United States, 36617
3
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72405
4
Cardiovascular Innovation and Research Center, Inc.
Long Beach, California, United States, 90813