Heart Failure Clinical Trial
Benefits of Microcor in Ambulatory Decompensated Heart Failure
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.
Full 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.
Eligibility Criteria
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.
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There are 74 Locations for this study
Sheffield Alabama, 35660, United States
El Cajon California, 92020, United States
Inglewood California, 90301, United States
Los Angeles California, 90036, United States
Mission Hills California, 91345, United States
San Diego California, 92119, United States
Aventura Florida, 33180, United States
Davenport Florida, 33837, United States
DeLand Florida, 32720, United States
Deltona Florida, 32725, United States
Fort Lauderdale Florida, 33308, United States
Hialeah Florida, 33013, United States
Hialeah Florida, 33013, United States
Miami Florida, 32032, United States
Miami Florida, 33155, United States
North Miami Florida, 33169, United States
Ocala Florida, 34471, United States
Orlando Florida, 32837, United States
Tamarac Florida, 33321, United States
Winter Haven Florida, 33880, United States
Winter Park Florida, 32792, United States
Atlanta Georgia, 30303, United States
Columbus Georgia, 31904, United States
Eatonton Georgia, 31024, United States
Quincy Illinois, 62301, United States
Munster Indiana, 46321, United States
Richmond Indiana, 47374, United States
South Bend Indiana, 46601, United States
Louisville Kentucky, 40205, United States
Owensboro Kentucky, 42303, United States
Hammond Louisiana, 70403, United States
Baltimore Maryland, 21784, United States
Pembroke Hills Maryland, 33024, United States
Salisbury Maryland, 21804, United States
Rochester Michigan, 48307, United States
Saginaw Michigan, 48601, United States
Jackson Mississippi, 48601, United States
Lee's Summit Missouri, 64064, United States
Saint Louis Missouri, 63128, United States
Saint Louis Missouri, 63136, United States
Lincoln Nebraska, 68506, United States
Omaha Nebraska, 68114, United States
Cherry Hill New Jersey, 08034, United States
Hackensack New Jersey, 07601, United States
Neptune New Jersey, 07753, United States
Bronx New York, 10457, United States
Cooperstown New York, 13326, United States
Rosedale New York, 11422, United States
Charlotte North Carolina, 28207, United States
Springfield Ohio, 45504, United States
Toledo Ohio, 43608, United States
Oklahoma City Oklahoma, 73112, United States
Hershey Pennsylvania, 17033, United States
Newtown Pennsylvania, 18940, United States
Pittsburgh Pennsylvania, 15212, United States
Smithfield Pennsylvania, 15478, United States
Lancaster South Carolina, 77598, United States
Knoxville Tennessee, 37934, United States
Allen Texas, 75013, United States
Cypress Texas, 77429, United States
Fort Worth Texas, 76104, United States
McKinney Texas, 75071, United States
McKinney Texas, 75071, United States
New Braunfels Texas, 78130, United States
Webster Texas, 77598, United States
Lynchburg Virginia, 24501, United States
Puyallup Washington, 98372, United States
Klagenfurt , 9020, Austria
Wien , 1100, Austria
Lille , 59037, France
Montpellier , 34295, France
Montpellier , , France
Paris , 75015, France
Paris , , France
Hamburg GG, 22457, Germany
Bad Nauheim , 06032, Germany
Bad Nauheim , , Germany
Frankfort , 60590, Germany
Gießen , 35392, Germany
Hamburg , , Germany
Hannover , 30625, Germany
Hannover , , Germany
Leipzig , 4289, Germany
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