Trial Outcomes & Findings for Benefits of µCor in Ambulatory Decompensated Heart Failure (NCT NCT03476187)

Last Updated: 2025-01-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

257 participants

Primary outcome timeframe

3 months

Results posted on

2025-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	µCor Wearers Subjects wearing the µCor device
Overall Study STARTED	257
Overall Study COMPLETED	245
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	µCor Wearers Subjects wearing the µCor device
Overall Study Protocol Violation	7
Overall Study Physician Decision	5

Baseline Characteristics

Benefits of µCor in Ambulatory Decompensated Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device
Age, Continuous	65.7 years STANDARD_DEVIATION 13.0 • n=99 Participants
Sex: Female, Male Female	101 Participants n=99 Participants
Sex: Female, Male Male	144 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity : Caucasian	154 participants n=99 Participants
Race/Ethnicity, Customized Ethnicity : Black or African American	62 participants n=99 Participants
Race/Ethnicity, Customized Ethnicity : Hispanic or Latin	16 participants n=99 Participants
Race/Ethnicity, Customized Ethnicity : Other	5 participants n=99 Participants
Race/Ethnicity, Customized Ethnicity : American Indian or Alaskan Native	2 participants n=99 Participants
Race/Ethnicity, Customized Ethnicity : Asian	1 participants n=99 Participants
Race/Ethnicity, Customized Ethnicity : Don't Know / No Response	1 participants n=99 Participants
Race/Ethnicity, Customized Ethnicity: Multiple Ethnicities	4 participants n=99 Participants
Region of Enrollment Austria	13 participants n=99 Participants
Region of Enrollment United States	221 participants n=99 Participants
Region of Enrollment Germany	11 participants n=99 Participants
Body Mass Index (BMI)	33.6 kg/m^2 STANDARD_DEVIATION 10.4 • n=99 Participants
Blood Pressure (systolic)	122.1 mmHg STANDARD_DEVIATION 19.3 • n=99 Participants
Blood Pressure (diastolic)	71.5 mmHg STANDARD_DEVIATION 12.2 • n=99 Participants
Respiration Rate	18.1 breaths per min STANDARD_DEVIATION 2.8 • n=99 Participants
Heart Rate	77 beats per min STANDARD_DEVIATION 14.5 • n=99 Participants
Years from Heart Failure Diagnosis	4.2 years STANDARD_DEVIATION 6.2 • n=99 Participants
Left Ventricular Ejection Fraction (Minimum)	38.7 % of blood ejected from left ventricle STANDARD_DEVIATION 17.4 • n=99 Participants
Left Ventricular Ejection Fraction (Maximum)	42.1 % of blood ejected from left ventricle STANDARD_DEVIATION 17.2 • n=99 Participants
Cardiac Device History History of Pacemaker · Yes	54 Participants n=99 Participants
Cardiac Device History History of Pacemaker · No	191 Participants n=99 Participants
Cardiac Device History History of Pacemaker · Unknown	0 Participants n=99 Participants
Cardiac Device History Pacemaker Active · Yes	50 Participants n=99 Participants
Cardiac Device History Pacemaker Active · No	4 Participants n=99 Participants
Cardiac Device History Pacemaker Active · Unknown	191 Participants n=99 Participants
Cardiac Device History History of ICD · Yes	72 Participants n=99 Participants
Cardiac Device History History of ICD · No	173 Participants n=99 Participants
Cardiac Device History History of ICD · Unknown	0 Participants n=99 Participants
Cardiac Device History ICD Active · Yes	67 Participants n=99 Participants
Cardiac Device History ICD Active · No	5 Participants n=99 Participants
Cardiac Device History ICD Active · Unknown	173 Participants n=99 Participants
Cardiac Device History Current Heart Failure Monitoring System · Yes	8 Participants n=99 Participants
Cardiac Device History Current Heart Failure Monitoring System · No	237 Participants n=99 Participants
Cardiac Device History Current Heart Failure Monitoring System · Unknown	0 Participants n=99 Participants
Heart Failure Etiology Ischemic	93 Participants n=99 Participants
Heart Failure Etiology Non-ischemic	136 Participants n=99 Participants
Heart Failure Etiology Mixed	16 Participants n=99 Participants
Medical History History of Hypertension · Yes	222 Participants n=99 Participants
Medical History History of Hypertension · No	22 Participants n=99 Participants
Medical History History of Hypertension · Unknown	1 Participants n=99 Participants
Medical History History of Diabetes · Yes	142 Participants n=99 Participants
Medical History History of Diabetes · No	103 Participants n=99 Participants
Medical History History of Diabetes · Unknown	0 Participants n=99 Participants
Medical History History of COPD · Yes	95 Participants n=99 Participants
Medical History History of COPD · No	146 Participants n=99 Participants
Medical History History of COPD · Unknown	4 Participants n=99 Participants
Medical History History of Transient Ischemic Attack · Yes	52 Participants n=99 Participants
Medical History History of Transient Ischemic Attack · No	189 Participants n=99 Participants
Medical History History of Transient Ischemic Attack · Unknown	4 Participants n=99 Participants
Medical History History of Chronic Kidney Disease · Yes	107 Participants n=99 Participants
Medical History History of Chronic Kidney Disease · No	134 Participants n=99 Participants
Medical History History of Chronic Kidney Disease · Unknown	4 Participants n=99 Participants
Medical History History of Angina · Yes	75 Participants n=99 Participants
Medical History History of Angina · No	161 Participants n=99 Participants
Medical History History of Angina · Unknown	9 Participants n=99 Participants
Medical History History of Syncope · Yes	43 Participants n=99 Participants
Medical History History of Syncope · No	192 Participants n=99 Participants
Medical History History of Syncope · Unknown	10 Participants n=99 Participants
Medical History History of Sudden Cardiac Arrest · Yes	8 Participants n=99 Participants
Medical History History of Sudden Cardiac Arrest · No	234 Participants n=99 Participants
Medical History History of Sudden Cardiac Arrest · Unknown	3 Participants n=99 Participants
Medical History History of Arrhythmia · Yes	155 Participants n=99 Participants
Medical History History of Arrhythmia · No	81 Participants n=99 Participants
Medical History History of Arrhythmia · Unknown	9 Participants n=99 Participants
Medical History History of Myocardial Infarction · Yes	78 Participants n=99 Participants
Medical History History of Myocardial Infarction · No	155 Participants n=99 Participants
Medical History History of Myocardial Infarction · Unknown	12 Participants n=99 Participants
Medical History History of Coronary Artery Bypass Graft (CABG) · Yes	49 Participants n=99 Participants
Medical History History of Coronary Artery Bypass Graft (CABG) · No	194 Participants n=99 Participants
Medical History History of Coronary Artery Bypass Graft (CABG) · Unknown	2 Participants n=99 Participants
Medical History History of Percutaneous Coronary Intervention (PCI) · Yes	74 Participants n=99 Participants
Medical History History of Percutaneous Coronary Intervention (PCI) · No	165 Participants n=99 Participants
Medical History History of Percutaneous Coronary Intervention (PCI) · Unknown	6 Participants n=99 Participants
New York Heart Classification Class I	3 Participants n=99 Participants
New York Heart Classification Class II	69 Participants n=99 Participants
New York Heart Classification Class III	122 Participants n=99 Participants
New York Heart Classification Class IV	9 Participants n=99 Participants
New York Heart Classification Not documented	42 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Correlation of μCor Readings to Heart Failure Related Clinical Events No valid device data within time window : HF Event	16 participants	—	—	—
Correlation of μCor Readings to Heart Failure Related Clinical Events Valid device data within time window : HF Event	34 participants	—	—	—
Correlation of μCor Readings to Heart Failure Related Clinical Events Valid device data within time window : No HF Event	173 participants	—	—	—
Correlation of μCor Readings to Heart Failure Related Clinical Events No valid device data within time window : No HF Event	22 participants	—	—	—

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Correlation of µCor Readings to Heart Failure Related Clinical Events Daytime Activity	0.35 Probability Interval 0.26 to 0.45	—	—	—
Correlation of µCor Readings to Heart Failure Related Clinical Events Nighttime Heart Rate	0.59 Probability Interval 0.48 to 0.7	—	—	—
Correlation of µCor Readings to Heart Failure Related Clinical Events Thoracic Fluid Index	0.59 Probability Interval 0.49 to 0.68	—	—	—
Correlation of µCor Readings to Heart Failure Related Clinical Events Nighttime Posture	0.59 Probability Interval 0.49 to 0.7	—	—	—
Correlation of µCor Readings to Heart Failure Related Clinical Events Nighttime Respiration	0.59 Probability Interval 0.48 to 0.7	—	—	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects VT at baseline	10 participants	—	—	—
Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects VF at baseline	3 participants	—	—	—
Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects VT (non-sustained) at baseline	12 participants	—	—	—
Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects Arrhythmic death at 1 year	2 participants	—	—	—
Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects Arrhythmic death at 90 days	1 participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Orthopnea - RR	0.55 Probability Interval 0.47 to 0.64	—	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Fatigue - TFI	0.57 Probability Interval 0.5 to 0.63	—	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Fatigue - HR	0.55 Probability Interval 0.48 to 0.62	—	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Fatigue - RR	0.47 Probability Interval 0.4 to 0.54	—	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Dyspnea - TFI	0.56 Probability Interval 0.49 to 0.62	—	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Dyspnea - HR	0.53 Probability Interval 0.46 to 0.6	—	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Dyspnea - RR	0.47 Probability Interval 0.4 to 0.54	—	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Orthopnea - TFI	0.54 Probability Interval 0.46 to 0.62	—	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve Orthopnea - HR	0.59 Probability Interval 0.51 to 0.67	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms n=245 Participants Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Orthopnea - TFI	206 Symptoms	65 Symptoms	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Orthopnea - HR	190 Symptoms	57 Symptoms	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Fatigue - HR	120 Symptoms	126 Symptoms	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Dyspnea - TFI	147 Symptoms	124 Symptoms	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Dyspnea - HR	135 Symptoms	117 Symptoms	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Dyspnea - RR	136 Symptoms	124 Symptoms	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Orthopnea - RR	197 Symptoms	64 Symptoms	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Fatigue - TFI	134 Symptoms	141 Symptoms	—	—
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms Fatigue - RR	128 Symptoms	130 Symptoms	—	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=228 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Frequency of Subject Reported Symptoms Frequency of self-reported heart failure symptoms · 6+ Arrhythmia symptoms	13 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported arrhythmia symptoms · 0 Arrhythmia symptoms	123 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported arrhythmia symptoms · 1 Arrhythmia symptom	52 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported arrhythmia symptoms · 2 Arrhythmia symptoms	22 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported arrhythmia symptoms · 3 Arrhythmia symptoms	17 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported arrhythmia symptoms · 4 Arrhythmia symptoms	3 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported arrhythmia symptoms · 5 Arrhythmia symptoms	8 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported arrhythmia symptoms · 6+ Arrhythmia symptoms	3 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported heart failure symptoms · 0 Arrhythmia symptoms	83 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported heart failure symptoms · 1 Arrhythmia symptom	62 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported heart failure symptoms · 2 Arrhythmia symptoms	30 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported heart failure symptoms · 3 Arrhythmia symptoms	21 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported heart failure symptoms · 4 Arrhythmia symptoms	9 Participants	—	—	—
Frequency of Subject Reported Symptoms Frequency of self-reported heart failure symptoms · 5 Arrhythmia symptoms	10 Participants	—	—	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=228 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Timing of Subject Reported Symptoms Time from start of study until first arrhythmia symptom report (median, interquartile range)	4 Weeks Interval 2.0 to 6.0	—	—	—
Timing of Subject Reported Symptoms Time from start of study until first heart failure symptom report (median, interquartile range)	3 Weeks Interval 2.0 to 5.0	—	—	—

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms n=245 Participants Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 n=245 Participants Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 n=245 Participants Subjects wearing the uCor during Month 3
Severity of Subject Reported Symptoms Severity of Dyspnea · Seldom	53 Participants	55 Participants	40 Participants	35 Participants
Severity of Subject Reported Symptoms Severity of Dyspnea · None	31 Participants	31 Participants	28 Participants	26 Participants
Severity of Subject Reported Symptoms Severity of Dyspnea · Continuous	21 Participants	16 Participants	8 Participants	7 Participants
Severity of Subject Reported Symptoms Severity of Dyspnea · Frequent	132 Participants	61 Participants	53 Participants	43 Participants
Severity of Subject Reported Symptoms Severity of Dyspnea · No data	8 Participants	82 Participants	116 Participants	134 Participants
Severity of Subject Reported Symptoms Severity of Orthopnea · Continuous	21 Participants	15 Participants	8 Participants	6 Participants
Severity of Subject Reported Symptoms Severity of Orthopnea · Frequent	72 Participants	35 Participants	16 Participants	18 Participants
Severity of Subject Reported Symptoms Severity of Orthopnea · Seldom	62 Participants	44 Participants	40 Participants	24 Participants
Severity of Subject Reported Symptoms Severity of Orthopnea · None	82 Participants	69 Participants	66 Participants	63 Participants
Severity of Subject Reported Symptoms Severity of Orthopnea · No data	8 Participants	82 Participants	115 Participants	134 Participants
Severity of Subject Reported Symptoms Severity of Fatigue · Continuous	35 Participants	22 Participants	19 Participants	16 Participants
Severity of Subject Reported Symptoms Severity of Fatigue · Frequent	114 Participants	62 Participants	48 Participants	37 Participants
Severity of Subject Reported Symptoms Severity of Fatigue · Seldom	55 Participants	50 Participants	41 Participants	37 Participants
Severity of Subject Reported Symptoms Severity of Fatigue · None	33 Participants	29 Participants	22 Participants	21 Participants
Severity of Subject Reported Symptoms Severity of Fatigue · No data	8 Participants	82 Participants	115 Participants	134 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Number of subjects hospitalized primarily for heart failure within 90 days

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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Hospital Readmission Rate During the Study Period	50 Participants	—	—	—

SECONDARY outcome

Timeframe: 3 months

Population: Number of subjects with a hospitalization in the 90 days prior to enrollment

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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study	206 Participants	—	—	—

SECONDARY outcome

Timeframe: 3 months

Population: Number of hospitalizations per subject during the 90 days prior to enrollment

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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study	2 Hospitalizations Interval 1.0 to 2.0	—	—	—

SECONDARY outcome

Timeframe: 6 months and 1 year

Population: Subjects enrolled in the study at 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.

Outcome measures

Outcome measures
Measure	µCor Wearers n=245 Participants Subjects wearing the µCor device	uCor Wearers With Severe Symptoms n=245 Participants Subjects wearing the uCor device with Severe Symptoms	uCor Wearers - Month 2 Subjects wearing the uCor during Month 2	uCor Wearers - Month 3 Subjects wearing the uCor during Month 3
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	62 Participants	—	—
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	31 Participants	—	—
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	77 Participants	—	—
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	137 Participants	—	—
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	117 Participants	—	—

Adverse Events

µCor Wearers

Serious events: 1 serious events

Other events: 149 other events

Deaths: 35 deaths

Serious adverse events

Serious adverse events
Measure	µCor Wearers n=257 participants at risk Subjects wearing the µCor device
Injury, poisoning and procedural complications Procedural Complication to ECHO	0.39% 1/257 • Number of events 1 • 1 Year All adverse events in the study that were causally related to the use of μCor were recorded as adverse device effects (ADEs). Each ADE was classified by the investigator as anticipated or unanticipated and then assessed for seriousness. An unanticipated ADE was defined as any ADE not identified by nature, severity, or frequency prior to the study.

Other adverse events

Other adverse events
Measure	µCor Wearers n=257 participants at risk Subjects wearing the µCor device
Product Issues Discomfort	1.2% 3/257 • Number of events 3 • 1 Year All adverse events in the study that were causally related to the use of μCor were recorded as adverse device effects (ADEs). Each ADE was classified by the investigator as anticipated or unanticipated and then assessed for seriousness. An unanticipated ADE was defined as any ADE not identified by nature, severity, or frequency prior to the study.
Skin and subcutaneous tissue disorders Skin Irritation	56.8% 146/257 • Number of events 146 • 1 Year All adverse events in the study that were causally related to the use of μCor were recorded as adverse device effects (ADEs). Each ADE was classified by the investigator as anticipated or unanticipated and then assessed for seriousness. An unanticipated ADE was defined as any ADE not identified by nature, severity, or frequency prior to the study.

Additional Information

Nicole Bianco

ZOLL

Phone: 4129683333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place