N/A N=257 Diagnostic

Benefits of µCor in Ambulatory Decompensated Heart Failure

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03476187 ↗

Enrolled (actual)

257

Serious AEs

0.4%

Results posted

Aug 2024

Primary outcome: Primary: Correlation of μCor Readings to Heart Failure Related Clinical Events — 34; 173; 16; 22 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: µCor (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Zoll Medical Corporation
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation of μCor Readings to Heart Failure Related Clinical Events	34; 173; 16; 22	—
PRIMARY Correlation of µCor Readings to Heart Failure Related Clinical Events	0.35; 0.59; 0.59; 0.59; 0.59	—
SECONDARY Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects	10; 3; 12; 2; 1	—
SECONDARY Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve	0.56; 0.53; 0.47; 0.54; 0.59; 0.55	—
SECONDARY Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms	147; 124; 135; 117; 136; 124	—
SECONDARY Frequency of Subject Reported Symptoms	123; 52; 22; 17; 3; 8	—
SECONDARY Timing of Subject Reported Symptoms	4; 3	—
SECONDARY Severity of Subject Reported Symptoms	21; 16; 8; 7; 132; 61	—
SECONDARY Hospital Readmission Rate During the Study Period	50	—
SECONDARY Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study	2	—
SECONDARY Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study	2	—
SECONDARY Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment	21; 31; 68; 77; 127; 137	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03476187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.