Benefits of Microcor in Ambulatory Decompensated Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT04096040

Run by

Zoll Medical Corporation

People needed

265

Starts

2019-11-01

Expected to finish

2023-10-30

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…

• 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.

You may not qualify if…

• 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 subcutaneous implantable cardio defibrillator (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 a Left Ventricular Assist Device (LVAD).
• 4.2.10 Subjects with self-reported pregnancy.
• 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Where it is running

• 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
• Holy Cross Hospital, Medical Group, Cardiology Associates — Fort Lauderdale, Florida, United States
• Elite Cardiac Research Center — Hialeah, Florida, United States
• Inpatient Research Clinic — Hialeah, Florida, United States
• Homestead Associates in Research — Miami, Florida, United States
• Westchester Research Center at Westchester General Hospital — Miami, Florida, United States
• Miramax Clinical Research Inc — North Miami, Florida, United States
• Ocala Cardiovascular Research — Ocala, Florida, United States
• Accel Research Sites — Orlando, Florida, United States
• DBC Research — Tamarac, Florida, United States
• Winter Haven Hospital - BayCare Health System — Winter Haven, Florida, United States
• Accel Research Sites - Guardian Winter Park — Winter Park, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Columbus Cardiology Associates — Columbus, Georgia, United States
• Accel Research Sites - Lake County Medical Group — Eatonton, Georgia, United States
• Quincy Medical Group — Quincy, Illinois, United States
• SYED Research Consultants LLC — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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