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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.
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.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
SYED Research Consultants LLC
Sheffield, Alabama, United States
TriWest Research
El Cajon, California, United States
Zillan Clinical Research
Inglewood, California, United States
Axis Clinical Trials
Los Angeles, California, United States
InvivoCure LLC
Mission Hills, California, United States
ACRC Studies
San Diego, California, United States
Aventura Clinical Research LLC
Aventura, Florida, United States
Accel Research Sites - Guardian
Davenport, Florida, United States
Accel Research Sites- Daytona Heart Group
DeLand, Florida, United States
Accel Research Sites - Guardian Winter Park
Deltona, Florida, United States
Start Date
November 1, 2019
Primary Completion Date
June 30, 2023
Completion Date
October 30, 2023
Last Updated
January 8, 2025
265
ACTUAL participants
μCor
DEVICE
Lead Sponsor
Zoll Medical Corporation
NCT07191730
NCT07484009
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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