Benefits of µCor in Ambulatory Decompensated Heart Failure

Zoll Medical Corporation257 enrolled

Overview

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.

Subjects meeting the inclusion/exclusion criteria will wear µCor for 90 days from the day of fitting. 500 total patients will be enrolled. There will be an interim analysis when the 200th subject has finished the study in the study to assess for distribution of patients with reduced and preserved LVEF. Subjects will be fitted with µCor during hospital discharge or within a clinic visit that has occurred within 10 days of a heart failure related hospitalization. The µCor fitting will mark day 0 of the study. An LVEF measurement will be recorded during enrollment or within 30 days post enrollment if an LVEF measurement has not been recorded within 30 days prior to enrollment. An investigator assessment will be performed during all clinic visits. The assessment template is shown in Appendix A. Subjects will be given a diary at enrollment that will ask them to rate their degree of specific symptoms of heart failure such as shortness of breath and fatigue as well as mark any heart failure related clinical events or medication changes that have occurred since the last entry. Study follow up visits will occur at day 30, day 60, and day 90. During follow up visits the subjects will be asked about any heart failure related clinical events or change in symptoms that have occurred since the last follow up. The subject will receive a study based weekly phone call asking the subject about any recent heart failure related clinical events or change in heart failure symptoms. During the weekly phone call the subject will be reminded to fill out the daily diary. No phone calls will be given on the week where there is a study follow up visit. There will be 9 total phone calls. During the Day 90 visit, the subject will be given the option to continue wearing the µCor for an additional 90 days. Furthermore, if the subject experienced a heart failure related clinical event within the initial 90 days of wear, the subject will be given the option of wearing the µCor for 30 days following the heart failure event. .If the subject chooses additional wear time, weekly phone calls and monthly visits will be structured identical to that of the main study period. The µCor will be returned at end of use. There will be a follow up at six months and one year post enrollment to document mortality data, heart failure related clinical events, and health care utilization data.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (61)

Mobile Heart Specialists, PC

Mobile, Alabama, United States

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

Outcomes

Primary Outcomes

Correlation of μCor Readings to Heart Failure Related Clinical Events

HF Event: a hospitalization primarily due to heart failure within 90 days. Time window: The 7 days prior to the 1st heart failure hospitalization, or the final 7 days of device wear if no HF event occurred.

Time frame: 3 months

Correlation of µCor Readings to Heart Failure Related Clinical Events

Definitions: Daytime: 7:00 AM - 12:00 AM Nighttime: 12:00 AM - 7:00 AM For each day on which the subject wore the device, the following values were calculated: Daytime activity: The proportion of minutes while wearing the device that the subject spent active (unitless). Nighttime heart rate: The median heart rate while wearing the device during the night (beats/min) Thoracic fluid index: The median proportion of ratio of radiofrequency-measured lung fluid readings compared to the subject's baseline (unitless). Nighttime posture: The median pitch angle while wearing the device during the night (degrees, where 0 is the horizontal). Nighttime respiration: The median respiration rate while wearing the device during the night (breaths/min) HF event: a hospitalization primarily due to heart failure

Time frame: 3 months

Secondary Outcomes

Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects

Rate of occurrence of VT/VF episodes at the time of enrollment in the study and rate of occurrence of arrhythmic death in subjects at 90 days and 1 year.

Time frame: Baseline, 90 days, 1 YR

Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve

During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: \[none, seldom, frequent, continuous\]. Each day that the subject wore the device, a daily median was calculated for the following measures: \[thoracic fluid index (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)\]. Nighttime was defined as 12:00 AM - 7:00 AM.

Time frame: 3 months

Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms

Time frame: 3 months

Frequency of Subject Reported Symptoms

During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the number of times that subjects reported each of these two symptoms.

Time frame: 3 months

Timing of Subject Reported Symptoms

During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the median number of weeks until a subject's first symptom report of each type.

Time frame: 3 months

Severity of Subject Reported Symptoms

Each subject was expected to undergo an in-person office visit at the site on months 0, 1, 2, and 3 in which they reported the severity of their heart failure symptoms. Results indicate the number of subjects reporting each severity level of each symptom at each office visit.

Time frame: 3 months

Hospital Readmission Rate During the Study Period

During weekly phone calls and monthly office visits, subjects reported whether they experienced a new hospitalization since their last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not.

Time frame: 3 months

Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study

At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the number of subjects who reported a hospitalization in this time window.

Time frame: 3 months

Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study

At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the median number of hospitalizations reported per subject in this time window.

Time frame: 3 months

Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment

During weekly phone calls, monthly office visits, the 6-month phone call, and the 1-year phone call, subjects reported whether they experienced a hospitalization, ER visit, or unplanned doctor's office visit since the last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not. On each subject's final date of study participation, their survival status was recorded.

Time frame: 6 months and 1 year

Benefits of µCor in Ambulatory Decompensated Heart Failure

Overview

Conditions

Interventions

Eligibility

Locations (61)

Outcomes

Primary Outcomes

Secondary Outcomes