Heart Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEµCor
Monitor with µCor
Sponsors
Zoll Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of μCor Readings to Heart Failure Related Clinical Events | 3 months | 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. |
| Correlation of µCor Readings to Heart Failure Related Clinical Events | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | 3 months | 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. |
| Frequency of Subject Reported Symptoms | 3 months | 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. |
| Timing of Subject Reported Symptoms | 3 months | 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. |
| Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects | Baseline, 90 days, 1 YR | 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. |
| Hospital Readmission Rate During the Study Period | 3 months | 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. |
| Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study | 3 months | 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. |
| Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | 6 months and 1 year | 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. |
| Severity of Subject Reported Symptoms | 3 months | 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. |
| Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | 3 months | 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. |
Countries
Austria, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| µCor Wearers Subjects wearing the µCor device | 245 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 5 |
| Overall Study | Protocol Violation | 7 |
Baseline characteristics
| Characteristic | µCor Wearers |
|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 13 |
| Blood Pressure (diastolic) | 71.5 mmHg STANDARD_DEVIATION 12.2 |
| Blood Pressure (systolic) | 122.1 mmHg STANDARD_DEVIATION 19.3 |
| Body Mass Index (BMI) | 33.6 kg/m^2 STANDARD_DEVIATION 10.4 |
| Cardiac Device History Current Heart Failure Monitoring System No | 237 Participants |
| Cardiac Device History Current Heart Failure Monitoring System Unknown | 0 Participants |
| Cardiac Device History Current Heart Failure Monitoring System Yes | 8 Participants |
| Cardiac Device History History of ICD No | 173 Participants |
| Cardiac Device History History of ICD Unknown | 0 Participants |
| Cardiac Device History History of ICD Yes | 72 Participants |
| Cardiac Device History History of Pacemaker No | 191 Participants |
| Cardiac Device History History of Pacemaker Unknown | 0 Participants |
| Cardiac Device History History of Pacemaker Yes | 54 Participants |
| Cardiac Device History ICD Active No | 5 Participants |
| Cardiac Device History ICD Active Unknown | 173 Participants |
| Cardiac Device History ICD Active Yes | 67 Participants |
| Cardiac Device History Pacemaker Active No | 4 Participants |
| Cardiac Device History Pacemaker Active Unknown | 191 Participants |
| Cardiac Device History Pacemaker Active Yes | 50 Participants |
| Heart Failure Etiology Ischemic | 93 Participants |
| Heart Failure Etiology Mixed | 16 Participants |
| Heart Failure Etiology Non-ischemic | 136 Participants |
| Heart Rate | 77 beats per min STANDARD_DEVIATION 14.5 |
| Left Ventricular Ejection Fraction (Maximum) | 42.1 % of blood ejected from left ventricle STANDARD_DEVIATION 17.2 |
| Left Ventricular Ejection Fraction (Minimum) | 38.7 % of blood ejected from left ventricle STANDARD_DEVIATION 17.4 |
| Medical History History of Angina No | 161 Participants |
| Medical History History of Angina Unknown | 9 Participants |
| Medical History History of Angina Yes | 75 Participants |
| Medical History History of Arrhythmia No | 81 Participants |
| Medical History History of Arrhythmia Unknown | 9 Participants |
| Medical History History of Arrhythmia Yes | 155 Participants |
| Medical History History of Chronic Kidney Disease No | 134 Participants |
| Medical History History of Chronic Kidney Disease Unknown | 4 Participants |
| Medical History History of Chronic Kidney Disease Yes | 107 Participants |
| Medical History History of COPD No | 146 Participants |
| Medical History History of COPD Unknown | 4 Participants |
| Medical History History of COPD Yes | 95 Participants |
| Medical History History of Coronary Artery Bypass Graft (CABG) No | 194 Participants |
| Medical History History of Coronary Artery Bypass Graft (CABG) Unknown | 2 Participants |
| Medical History History of Coronary Artery Bypass Graft (CABG) Yes | 49 Participants |
| Medical History History of Diabetes No | 103 Participants |
| Medical History History of Diabetes Unknown | 0 Participants |
| Medical History History of Diabetes Yes | 142 Participants |
| Medical History History of Hypertension No | 22 Participants |
| Medical History History of Hypertension Unknown | 1 Participants |
| Medical History History of Hypertension Yes | 222 Participants |
| Medical History History of Myocardial Infarction No | 155 Participants |
| Medical History History of Myocardial Infarction Unknown | 12 Participants |
| Medical History History of Myocardial Infarction Yes | 78 Participants |
| Medical History History of Percutaneous Coronary Intervention (PCI) No | 165 Participants |
| Medical History History of Percutaneous Coronary Intervention (PCI) Unknown | 6 Participants |
| Medical History History of Percutaneous Coronary Intervention (PCI) Yes | 74 Participants |
| Medical History History of Sudden Cardiac Arrest No | 234 Participants |
| Medical History History of Sudden Cardiac Arrest Unknown | 3 Participants |
| Medical History History of Sudden Cardiac Arrest Yes | 8 Participants |
| Medical History History of Syncope No | 192 Participants |
| Medical History History of Syncope Unknown | 10 Participants |
| Medical History History of Syncope Yes | 43 Participants |
| Medical History History of Transient Ischemic Attack No | 189 Participants |
| Medical History History of Transient Ischemic Attack Unknown | 4 Participants |
| Medical History History of Transient Ischemic Attack Yes | 52 Participants |
| New York Heart Classification Class I | 3 Participants |
| New York Heart Classification Class II | 69 Participants |
| New York Heart Classification Class III | 122 Participants |
| New York Heart Classification Class IV | 9 Participants |
| New York Heart Classification Not documented | 42 Participants |
| Race/Ethnicity, Customized Ethnicity : American Indian or Alaskan Native | 2 participants |
| Race/Ethnicity, Customized Ethnicity : Asian | 1 participants |
| Race/Ethnicity, Customized Ethnicity : Black or African American | 62 participants |
| Race/Ethnicity, Customized Ethnicity : Caucasian | 154 participants |
| Race/Ethnicity, Customized Ethnicity : Don't Know / No Response | 1 participants |
| Race/Ethnicity, Customized Ethnicity : Hispanic or Latin | 16 participants |
| Race/Ethnicity, Customized Ethnicity: Multiple Ethnicities | 4 participants |
| Race/Ethnicity, Customized Ethnicity : Other | 5 participants |
| Region of Enrollment Austria | 13 participants |
| Region of Enrollment Germany | 11 participants |
| Region of Enrollment United States | 221 participants |
| Respiration Rate | 18.1 breaths per min STANDARD_DEVIATION 2.8 |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 144 Participants |
| Years from Heart Failure Diagnosis | 4.2 years STANDARD_DEVIATION 6.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 35 / 257 |
| other Total, other adverse events | 149 / 257 |
| serious Total, serious adverse events | 1 / 257 |
Outcome results
Primary
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
Population: The median was calculated for the 7 days prior to the 1st hospitalization; the median was calculated for the final 7 days of device wear. ROC analysis was performed. Data are presented assuming that the device reading in subjects without events is less than that of subjects with events. Unit of measure: probability that a randomly chosen subject with a HF event has a greater device value than a randomly chosen subject without a HF event.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| µCor Wearers | Correlation of µCor Readings to Heart Failure Related Clinical Events | Daytime Activity | 0.35 Probability |
| µCor Wearers | Correlation of µCor Readings to Heart Failure Related Clinical Events | Nighttime Heart Rate | 0.59 Probability |
| µCor Wearers | Correlation of µCor Readings to Heart Failure Related Clinical Events | Thoracic Fluid Index | 0.59 Probability |
| µCor Wearers | Correlation of µCor Readings to Heart Failure Related Clinical Events | Nighttime Posture | 0.59 Probability |
| µCor Wearers | Correlation of µCor Readings to Heart Failure Related Clinical Events | Nighttime Respiration | 0.59 Probability |
Primary
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
Population: The median of each device value was calculated for each subject within their time window. ROC analysis was performed. Data are presented assuming that the device reading in subjects without HF events \< that of subjects with HF events.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| µCor Wearers | Correlation of μCor Readings to Heart Failure Related Clinical Events | Valid device data within time window : HF Event | 34 participants |
| µCor Wearers | Correlation of μCor Readings to Heart Failure Related Clinical Events | Valid device data within time window : No HF Event | 173 participants |
| µCor Wearers | Correlation of μCor Readings to Heart Failure Related Clinical Events | No valid device data within time window : HF Event | 16 participants |
| µCor Wearers | Correlation of μCor Readings to Heart Failure Related Clinical Events | No valid device data within time window : No HF Event | 22 participants |
Secondary
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
Population: The median of the daily medians for each device measure was calculated for the 7 days preceding each office visit. To assess whether reports of severe \[frequent or continuous\] symptoms were associated with greater device measures than reports of mild symptoms \[none or seldom\], receiver operating characteristic (ROC) analysis was performed. Unit of measure: probability a randomly chosen subject with severe symptoms has a greater device value than a randomly chosen subject with mild symptoms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Dyspnea - TFI | 0.56 Probability |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Dyspnea - HR | 0.53 Probability |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Dyspnea - RR | 0.47 Probability |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Orthopnea - TFI | 0.54 Probability |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Orthopnea - HR | 0.59 Probability |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Orthopnea - RR | 0.55 Probability |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Fatigue - TFI | 0.57 Probability |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Fatigue - HR | 0.55 Probability |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve | Fatigue - RR | 0.47 Probability |
Secondary
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms
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
Population: The results indicate the number of mild or severe symptom reports preceded by a valid device measure. Each of the 245 participants in the study could contribute data to either Arm/Group depending on the severity of their symptoms across the 3-month study duration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Fatigue - TFI | 134 Symptoms |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Dyspnea - TFI | 147 Symptoms |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Dyspnea - HR | 135 Symptoms |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Dyspnea - RR | 136 Symptoms |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Orthopnea - TFI | 206 Symptoms |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Orthopnea - HR | 190 Symptoms |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Orthopnea - RR | 197 Symptoms |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Fatigue - HR | 120 Symptoms |
| µCor Wearers | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Fatigue - RR | 128 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Fatigue - RR | 130 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Orthopnea - HR | 57 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Dyspnea - TFI | 124 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Fatigue - HR | 126 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Dyspnea - HR | 117 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Orthopnea - RR | 64 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Dyspnea - RR | 124 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Fatigue - TFI | 141 Symptoms |
| uCor Wearers With Severe Symptoms | Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms | Orthopnea - TFI | 65 Symptoms |
Secondary
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
Population: Rate of occurrence of VT/VF episodes at the time of enrollment in the study and rate of occurrence of arrhythmic death at 90 days and 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| µCor Wearers | Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects | VT at baseline | 10 participants |
| µCor Wearers | Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects | VF at baseline | 3 participants |
| µCor Wearers | Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects | VT (non-sustained) at baseline | 12 participants |
| µCor Wearers | Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects | Arrhythmic death at 1 year | 2 participants |
| µCor Wearers | Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects | Arrhythmic death at 90 days | 1 participants |
Secondary
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
Population: 228 subjects completed at least one weekly phone call or monthly office visit case report form in which they could self-report arrhythmia and heart failure symptoms
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported arrhythmia symptoms | 0 Arrhythmia symptoms | 123 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported arrhythmia symptoms | 1 Arrhythmia symptom | 52 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported arrhythmia symptoms | 2 Arrhythmia symptoms | 22 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported arrhythmia symptoms | 3 Arrhythmia symptoms | 17 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported arrhythmia symptoms | 4 Arrhythmia symptoms | 3 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported arrhythmia symptoms | 5 Arrhythmia symptoms | 8 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported arrhythmia symptoms | 6+ Arrhythmia symptoms | 3 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported heart failure symptoms | 0 Arrhythmia symptoms | 83 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported heart failure symptoms | 1 Arrhythmia symptom | 62 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported heart failure symptoms | 2 Arrhythmia symptoms | 30 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported heart failure symptoms | 3 Arrhythmia symptoms | 21 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported heart failure symptoms | 4 Arrhythmia symptoms | 9 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported heart failure symptoms | 5 Arrhythmia symptoms | 10 Participants |
| µCor Wearers | Frequency of Subject Reported Symptoms | Frequency of self-reported heart failure symptoms | 6+ Arrhythmia symptoms | 13 Participants |
Secondary
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
Population: Number of subjects with a hospitalization in the 90 days prior to enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| µCor Wearers | Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study | 206 Participants |
Secondary
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
Population: Number of hospitalizations per subject during the 90 days prior to enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| µCor Wearers | Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study | 2 Hospitalizations |
Secondary
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
Population: Number of subjects hospitalized primarily for heart failure within 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| µCor Wearers | Hospital Readmission Rate During the Study Period | 50 Participants |
Secondary
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
Population: Subjects enrolled in the study at 6 months and 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| µCor Wearers | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Heart Failure (HF) Related Events: Number of subjects with a hospital readmission for HF | 68 Participants |
| µCor Wearers | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Health Care Utilization: Number of subjects with an Emergency Room visit for any reason | 109 Participants |
| µCor Wearers | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Health Care Utilization: Number of subjects with a hospitalization for any reason | 127 Participants |
| µCor Wearers | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Health Care Utilization: Number of subjects with an unplanned doctor's office visit for any reason | 54 Participants |
| µCor Wearers | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Mortality: Number of subjects reported dead | 21 Participants |
| uCor Wearers With Severe Symptoms | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Health Care Utilization: Number of subjects with an unplanned doctor's office visit for any reason | 62 Participants |
| uCor Wearers With Severe Symptoms | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Mortality: Number of subjects reported dead | 31 Participants |
| uCor Wearers With Severe Symptoms | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Heart Failure (HF) Related Events: Number of subjects with a hospital readmission for HF | 77 Participants |
| uCor Wearers With Severe Symptoms | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Health Care Utilization: Number of subjects with a hospitalization for any reason | 137 Participants |
| uCor Wearers With Severe Symptoms | Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment | Health Care Utilization: Number of subjects with an Emergency Room visit for any reason | 117 Participants |
Secondary
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
Population: 245 subjects were enrolled in the study. Each subject was expected to undergo an in-person office visit at the site on months 0, 1, 2, and 3 in which they self-reported heart failure symptoms. Note that this analysis includes the initial office visit (month 0).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Dyspnea | Continuous | 21 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Fatigue | Frequent | 114 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Orthopnea | None | 82 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Dyspnea | Seldom | 53 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Orthopnea | No data | 8 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Fatigue | Continuous | 35 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Dyspnea | None | 31 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Dyspnea | Frequent | 132 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Fatigue | None | 33 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Dyspnea | No data | 8 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Orthopnea | Continuous | 21 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Fatigue | Seldom | 55 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Orthopnea | Frequent | 72 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Fatigue | No data | 8 Participants |
| µCor Wearers | Severity of Subject Reported Symptoms | Severity of Orthopnea | Seldom | 62 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Orthopnea | Seldom | 44 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Fatigue | Frequent | 62 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Dyspnea | No data | 82 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Orthopnea | None | 69 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Dyspnea | Frequent | 61 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Fatigue | Continuous | 22 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Fatigue | Seldom | 50 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Orthopnea | No data | 82 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Dyspnea | Seldom | 55 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Orthopnea | Frequent | 35 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Fatigue | No data | 82 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Fatigue | None | 29 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Orthopnea | Continuous | 15 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Dyspnea | None | 31 Participants |
| uCor Wearers With Severe Symptoms | Severity of Subject Reported Symptoms | Severity of Dyspnea | Continuous | 16 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Orthopnea | Seldom | 40 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Dyspnea | Continuous | 8 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Dyspnea | Frequent | 53 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Dyspnea | Seldom | 40 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Dyspnea | None | 28 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Dyspnea | No data | 116 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Orthopnea | Continuous | 8 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Orthopnea | Frequent | 16 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Orthopnea | None | 66 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Orthopnea | No data | 115 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Fatigue | Continuous | 19 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Fatigue | Frequent | 48 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Fatigue | Seldom | 41 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Fatigue | None | 22 Participants |
| uCor Wearers - Month 2 | Severity of Subject Reported Symptoms | Severity of Fatigue | No data | 115 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Orthopnea | Frequent | 18 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Dyspnea | Frequent | 43 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Fatigue | Frequent | 37 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Orthopnea | Continuous | 6 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Dyspnea | No data | 134 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Dyspnea | Continuous | 7 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Fatigue | Seldom | 37 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Dyspnea | None | 26 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Dyspnea | Seldom | 35 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Fatigue | No data | 134 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Orthopnea | No data | 134 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Orthopnea | None | 63 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Fatigue | None | 21 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Fatigue | Continuous | 16 Participants |
| uCor Wearers - Month 3 | Severity of Subject Reported Symptoms | Severity of Orthopnea | Seldom | 24 Participants |
Secondary
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
Population: 228 subjects completed at least one weekly phone call or monthly office visit case report form in which they could self-report arrhythmia and heart failure symptoms
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| µCor Wearers | Timing of Subject Reported Symptoms | Time from start of study until first arrhythmia symptom report (median, interquartile range) | 4 Weeks |
| µCor Wearers | Timing of Subject Reported Symptoms | Time from start of study until first heart failure symptom report (median, interquartile range) | 3 Weeks |