N/A
N=265
Benefits of Microcor in Ambulatory Decompensated Heart Failure
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04096040 ↗Enrolled (actual)
265
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Data Updates Received by the uCor Subject Management System — 3 data updates per subject
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
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Data Updates Received by the uCor Subject Management System |
3 | — |
| PRIMARY Approximate Time Spent Reviewing Data Reports Assessment Across Sites (PO 2: Part 1/2) |
1548; 427; 132 | — |
| PRIMARY Approximate Time Spent Reviewing Data Reports Assessment Within Sites (PO 2: Part 2/2) |
34; 9; 1 | — |
| PRIMARY The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 1/3) |
114; 45 | — |
| PRIMARY The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 2/3) |
38; 19; 11 | — |
| PRIMARY The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 3/3) |
8; 2; 3; 4 | — |
| PRIMARY The Number of Medication Changes Based on Subject Incidental Findings |
58; 35; 20; 10; 8; 8 | — |
| PRIMARY Number of Times High μCor Measurements Were Reduced Below Threshold Levels After Medication Was Titrated or Lifestyle Modifications Were Recommended |
19; 21 | — |
| SECONDARY Strength of Association Between μCor Measurements and Clinically Related Heart Failure Events. |
0.57; 0.52; 0.57; 0.61; 0.45 | — |
| SECONDARY Strength of Association Between μCor Measurements and Subject Reported Symptoms |
0.54; 0.49; 0.52; 0.52; 0.53; 0.60 | — |
| SECONDARY Correlations Between uCor Measurements and Patient Reported Symptoms: Mild/Severe Symptoms |
255; 100; 253; 99; 254; 99 | — |
| SECONDARY Hospital Readmission Rate, Physician Visit Rate, and Outpatient Clinic Visit Rate During the Study Period |
32; 7 | — |
| SECONDARY Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Mortality Data |
20; 37; 229; 212 | — |
| SECONDARY Mortality Rate, Cause of Death, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Cause of Death |
2; 10; 1; 1; 12; 11 | — |
| SECONDARY Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Quality of Life Data |
32; 54.8; 58.2 | — |
| SECONDARY Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Healthcare Utilization Data |
120; 134; 101; 119; 55; 62 | — |
Summary
To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.
Eligibility Criteria
Inclusion Criteria
- 4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
- 4.1.2 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 in 4.1.1
- 4.1.3 Subjects 21 years of age or older on the day of screening.
Exclusion Criteria
- 4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
- 4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
- 4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
- 4.2.4 Subjects anticipated to start dialysis within 90 days.
- 4.2.5 Subjects currently implanted with an subcutaneous implantable cardio defibrillator (S-ICD) system.
- 4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
- 4.2.7 Subjects who are unable to participate in all follow up visits.
- 4.2.8 Subjects participating in research other than a registry at the time of enrollment.
- 4.2.9 Subjects currently implanted with a Left Ventricular Assist Device (LVAD).
- 4.2.10 Subjects with self-reported pregnancy.
- 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.
Data sourced from ClinicalTrials.gov (NCT04096040). 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.