Benefits of µCor in Ambulatory Decompensated Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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 will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned 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. 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.

Key facts

Study ID

NCT03476187

Run by

Zoll Medical Corporation

People needed

257

Starts

2018-08-17

Expected to finish

2024-04-09

Last updated by the study team

2025-01-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Hospital — Mobile, Alabama, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Cardiovascular Innovation and Research Center, Inc. — Long Beach, California, United States
• Los Alamitos Cardiovascular — Los Alamitos, California, United States
• Nova Clinical Research LLC — Bradenton, Florida, United States
• South Palm Cardiovascular Research Institute — Delray Beach, Florida, United States
• Holy Cross Medical Group — Fort Lauderdale, Florida, United States
• The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States
• Baptist Heart Specialists — Jacksonville, Florida, United States
• The Heart Institute at Largo — Largo, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Cardiovascular Institute of Central Florida — Ocala, Florida, United States
• Northside Hospital — St. Petersburg, Florida, United States
• University of South Florida Dept of Cardiovascular Sciences — Tampa, Florida, United States
• Cardiology Practice Tampa — Tampa, Florida, United States
• Cardiovascular Consultants of South Georgia — Thomasville, Georgia, United States
• Fox Valley Clinical Research Center — Aurora, Illinois, United States
• The Loretto Hospital — Chicago, Illinois, United States
• Chicago Medical Research LLC — Hazel Crest, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Unity Point Health Cardiovascular Services — Peoria, Illinois, United States
• DuPage Medical Group — Winfield, Illinois, United States
• Grace Research LLC — Bossier City, Louisiana, United States
• Clinical Trials of America, LLC — Monroe, Louisiana, United States
• Mobile Heart Specialists, PC — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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