N/A
N=51
Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)
Heart Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT04512703 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Logistics of Study Device Setup and Monitoring — 51; 51; 51; 51 count of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- µCor (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Zoll Medical Corporation
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Logistics of Study Device Setup and Monitoring |
51; 51; 51; 51; 22; 23 | — |
| PRIMARY Device Wear Time and Compliance |
68; 54 | — |
| PRIMARY Subject's Ability to Accurately Place Device |
96; 96 | — |
| PRIMARY Device Data Transmission and Device Connectivity |
51; 51; 22; 23 | — |
| PRIMARY Ability to Provide Timely Arrythmia Monitoring |
9.9; 10.5 | — |
| PRIMARY Documentation of Clinically Actionable Events. |
29; 42 | — |
| SECONDARY Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency |
23.4; 24.0 | — |
| SECONDARY Association of Device Recordings to Clinical Events |
5 | — |
| SECONDARY Device Recording Stability |
0.48; 0.41 | — |
| SECONDARY Respiration Rate Front and Side Device Measurement Equivalency |
16.9; 16.9 | — |
| SECONDARY Activity Front and Side Device Measurement Equivalency |
981; 1007 | — |
| SECONDARY Sleep Angle Front and Side Device Measurement Equivalency |
2.5; 2.3 | — |
Summary
Prospective, non-interventional, feasibility study. 8 months, from start of screening to finishing the study. Multi-center study, with a maximum of 8 centers in Europe. Health adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring.
To observe the feasibility of remotely monitoring patients with the novel µCor Heart Failure and Arrhythmia Management System (µCor system ) that non-invasively captures thoracic fluid content, electrocardiogram, heart rate, respiratory rate, activity, and body posture. tory outpatient cardiac monitoring.
Eligibility Criteria
-Inclusion Criteria
The following criteria will be used to include subjects in phase I portion of the study:
- Healthy male and female volunteers.
- Subjects older than 21 years of age.
- Subjects willing to wear the µCor device for up to 30 days.
- Subjects willing to answer weekly phone calls from the study staff.
The following criteria will be used to include subjects in phase II portion of the study:
- Patients with a clinical indication for outpatient cardiac monitoring.
- Patients older than 21 years of age.
- Patients willing to wear the µCor device for up to 90 days.
- Patients willing to make monthly (30-, 60-, and 90-day) office visits during the study period.
- Patients willing to answer weekly phone calls regarding their health status.
- Exclusion Criteria:
The following criteria will be used to exclude subjects from phases I and II portions of the study:
- Subjects reporting or planning to be pregnant.
- Subjects with any cardiac implantable electronic devices, including loop recorders.
- Subjects with a wearable cardioverter defibrillator.
- Subjects with Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices.
- Subjects with any skin condition that would prevent them from wearing the µCor system.
- Subjects who are non-ambulatory.
- Subjects without adequate cellular transmission access that would prevent data download from the µCor device.
- Subjects participating in another clinical study.
- Subjects unable to give informed consent.
- Employees of ZOLL or their family members.
- Subjects traveling during the study participation period that prevents planned office visits and weekly phone calls from the study coordinator.
- Subjects expected to undergo a planned MRI exam during the participation period.
Data sourced from ClinicalTrials.gov (NCT04512703). 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.