Protocol Description

Each year, over one million patients are hospitalized with a primary diagnosis of heart failure (HF)1. Despite improvement in outcomes with medical therapy, readmissions for acute decompensated HF are common, and place a significant burden on the healthcare system. Therefore, strategies for outpatient monitoring and fluid management are needed in order to reduce HF hospitalizations. Rather than low cardiac output, the main reasons for rehospitalization are symptoms associated with pulmonary and systemic venous congestion due to elevated ventricular filling (end-diastolic) pressures 2. Remote monitoring of these pressure changes, in addition to its surrogate measures, such as intrathoracic impedance, lung fluid levels, systolic time intervals, or the presence of abnormal heart sounds, may help to prevent hospitalization by detecting early evidence of HF decompensation3,4,5. In addition, remote monitoring may lead to better access to care and coordination of services.

Given the anticipated importance of remote HF monitoring and fluid management, ZOLL has developed a novel radio frequency-based (RF) heart failure and arrhythmia management system (µCor Heart Failure and Arrhythmia Management System). Using the RF data, µCor provides an estimate of the thoracic fluid index (TFI). To calculate TFI, the thoracic fluid baseline is determined, and the normalized value is presented as TFI. In conjunction with standard clinical practice for patients with fluid balance issues, the direction of change of TFI over time may provide clinically useful information. In addition to TFI, the system records the electrocardiogram (ECG) through adhesive electrodes and respiration rate, activity, and posture through a tri-axial accelerometer. The purpose of this study is to assess investigator engagement of µCor system data in the context of heart failure management.


Eligibility Criteria

You may be eligible to participate in this study if you meet the following criteria:

The following criteria will be used to include subjects in the study: An acute heart failure event requiring medical management will be defined by the study investigator. The index hospitalization and six-month prior event must have started two weeks apart from one another:

  • Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge
  • 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
  • Subjects 21 years of age or older on the day of screening


Clinical Trial Investigator

Dr. Jose David Suarez, Principal Investigator