Heart Arrhythmia
Conditions
Brief 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.
Detailed description
The study will consist of two phases. Phase I of the study will enroll 6 healthy volunteers, who have no indication for remote cardiac monitoring. Subjects are required to participate in the study for 30 days. Phase II of the study will enroll up to 44 patients indicated for outpatient cardiac monitoring and will participate in the study for up to 90 days. All subjects will wear the device in two locations, one along the left midaxillary line and the other along the left midclavicular line for the first seven days. Thereafter, for the remainder of the study, half the enrolled subjects will only wear the device in the left midclavicular position and the other half will wear the device in the left midaxillary position. Subjects will use a diary to keep a daily log their activities of daily living (phase I) or a log of any symptoms related to heart rhythm abnormalities and heart failure (phase II). Data will be acquired with the µCor system and wirelessly transmitted daily to a remote server for processing, generating thoracic fluid content, ECG, heart rate, respiration rate, activity, and posture measurements. Investigators will have access only to ECG data. Study staff will make weekly phone calls to subjects and record any new clinically actionable events. Patients will have monthly office visits. At the end of 30 days (phase I) or 90 days (phase II), patients will end wear and will complete the study follow-up questionnaire. The study will enroll a maximum of 50 subjects. Six healthy volunteers will be enrolled for phase I of the study. Remaining 44 subjects will be enrolled for phase II and will have an indication of outpatient cardiac monitoring.
Interventions
DEVICEµCor
Sensor Monitor for arrhythmia and other bio-metric markers
Sponsors
Zoll Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Documentation of Clinically Actionable Events. | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 | Assessed by the total number of clinical events documented including arrythmia symptoms, physician office visits, ER visits, hospitalizations, and mortality in both the healthy group and arrhythmia monitoring group. The number or clinical events documented was assessed irrespective of whether the device was being worn in Period 1 or Period 2. |
| Logistics of Study Device Setup and Monitoring | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 | Logistics will be assessed by the number of subjects successfully fitted with a device that was able to transmit data to the remote server. Device Setup |
| Device Wear Time and Compliance | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 | Total number of days the device is worn at least once, in the devices indicated for long term wear in the heart arryhthmia group. These devices were worn during both Period 1 and Period 2, and the outcome measure was assessed irrespective of whether the device was being worn in Period 1 or Period 2. |
| Subject's Ability to Accurately Place Device | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 | Subject Training will be assessed by measuring the incidence of correct device placement. Correct device placement was assessed irrespective of whether the device was being worn in Period 1 or Period 2. |
| Device Data Transmission and Device Connectivity | Period 1 and Period 2 | Count of subjects that had daily data transmission. |
| Ability to Provide Timely Arrythmia Monitoring | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 | Timely arrythmia monitoring will be assessed by the mean time from arrythmia event trigger to publication of arrythmia report to investigator. Timing or arrhythmia monitoring reporting was assessed irrespective of whether the device was being worn in Period 1 or Period 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency | Period 1: Start of device wear at Day 0 to Day 7 | The TFC measurement was compared between front and side placed devices. TFC is a unitless measurement that encompasses the degree of reflected radar waves in the lung taken by the study device. Higher TFC is indicative of increased fluid, whereas lower TFC is indicative of decreased fluid. |
| Association of Device Recordings to Clinical Events | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 | Device recordings were assessed and compared to clinical events in both the healthy group and arrhythmia monitoring group. Device recording associations were assessed irrespective of whether the device was being worn in Period 1 or Period 2. |
| Device Recording Stability | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 | Device recording stability was assessed through the heart rate coefficient of variation in both front and side placed devices. Stability was assessed irrespective of whether the device was being worn in Period 1 or Period 2. |
| Respiration Rate Front and Side Device Measurement Equivalency | Period 1: Start of device wear at Day 0 to Day 7 | Respiration rates were compared between front and side placed devices. The outcome was measured only during Period 1 when both front and side devices were worn simultaneously. |
| Activity Front and Side Device Measurement Equivalency | Period 1: Start of device wear at Day 0 to Day 7 | Activity counts were compared between front and side devices. |
| Sleep Angle Front and Side Device Measurement Equivalency | Period 1: Start of device wear at Day 0 to Day 7 | Sleep angle was compared between front and side devices. |
Countries
Germany
Participant flow
Pre-assignment details
An additional subject was enrolled beyond the protocol in the arrhythmia group.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Group Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.
µCor: Sensor Monitor for arrhythmia and other bio-metric markers | 6 |
| Arrhythmia Monitoring Group Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.
µCor: Sensor Monitor for arrhythmia and other bio-metric markers | 45 |
| Total | 51 |
Baseline characteristics
| Characteristic | Arrhythmia Monitoring Group | Total | Healthy Group |
|---|---|---|---|
| Age, Continuous | 61 years | 58 years | 35 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 45 participants | 51 participants | 6 participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 3 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 45 |
| other Total, other adverse events | 6 / 6 | 42 / 45 |
| serious Total, serious adverse events | 0 / 6 | 0 / 45 |
Outcome results
Primary
Ability to Provide Timely Arrythmia Monitoring
Timely arrythmia monitoring will be assessed by the mean time from arrythmia event trigger to publication of arrythmia report to investigator. Timing or arrhythmia monitoring reporting was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Front Position Devices | Ability to Provide Timely Arrythmia Monitoring | 9.9 hours | Standard Deviation 42.8 |
| Side Position Devices | Ability to Provide Timely Arrythmia Monitoring | 10.5 hours | Standard Deviation 55 |
Primary
Device Data Transmission and Device Connectivity
Count of subjects that had daily data transmission.
Time frame: Period 1 and Period 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Front Position Devices | Device Data Transmission and Device Connectivity | Devices Worn during Phase 1 | 51 count of participants |
| Front Position Devices | Device Data Transmission and Device Connectivity | Devices Worn during Phase 2 | 22 count of participants |
| Side Position Devices | Device Data Transmission and Device Connectivity | Devices Worn during Phase 1 | 51 count of participants |
| Side Position Devices | Device Data Transmission and Device Connectivity | Devices Worn during Phase 2 | 23 count of participants |
Primary
Device Wear Time and Compliance
Total number of days the device is worn at least once, in the devices indicated for long term wear in the heart arryhthmia group. These devices were worn during both Period 1 and Period 2, and the outcome measure was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Population: Devices on subjects in the arrythmia group that were allocated for 90 day wear were used in the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Front Position Devices | Device Wear Time and Compliance | 68 Days | Standard Deviation 29 |
| Side Position Devices | Device Wear Time and Compliance | 54 Days | Standard Deviation 36 |
Primary
Documentation of Clinically Actionable Events.
Assessed by the total number of clinical events documented including arrythmia symptoms, physician office visits, ER visits, hospitalizations, and mortality in both the healthy group and arrhythmia monitoring group. The number or clinical events documented was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Front Position Devices | Documentation of Clinically Actionable Events. | 29 documented clinical events |
| Side Position Devices | Documentation of Clinically Actionable Events. | 42 documented clinical events |
Primary
Logistics of Study Device Setup and Monitoring
Logistics will be assessed by the number of subjects successfully fitted with a device that was able to transmit data to the remote server. Device Setup
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Population: All devices in both Healthy and Arrythmia Monitoring Group were assessed for setup at the beginning of Period 1. Monitoring assessment was assessed during both Period 1 and Period 2. There was a total of 51 side position devices and 51 front position devices.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Front Position Devices | Logistics of Study Device Setup and Monitoring | Devices Assessed for Setup during Period 1 | 51 count of participants |
| Front Position Devices | Logistics of Study Device Setup and Monitoring | Devices Assessed for Monitoring during Period 1 | 51 count of participants |
| Front Position Devices | Logistics of Study Device Setup and Monitoring | Devices assessed for Monitoring during Period 2 | 22 count of participants |
| Side Position Devices | Logistics of Study Device Setup and Monitoring | Devices Assessed for Setup during Period 1 | 51 count of participants |
| Side Position Devices | Logistics of Study Device Setup and Monitoring | Devices Assessed for Monitoring during Period 1 | 51 count of participants |
| Side Position Devices | Logistics of Study Device Setup and Monitoring | Devices assessed for Monitoring during Period 2 | 23 count of participants |
Primary
Subject's Ability to Accurately Place Device
Subject Training will be assessed by measuring the incidence of correct device placement. Correct device placement was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Population: A position assessment and orientation placement was assessed for accuracy for all front and side devices.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Front Position Devices | Subject's Ability to Accurately Place Device | 96 percentage of correct placements |
| Side Position Devices | Subject's Ability to Accurately Place Device | 96 percentage of correct placements |
Secondary
Activity Front and Side Device Measurement Equivalency
Activity counts were compared between front and side devices.
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Population: Includes both healthy and arrhythmia monitoring groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Front Position Devices | Activity Front and Side Device Measurement Equivalency | 981 activity counts | Standard Deviation 934 |
| Side Position Devices | Activity Front and Side Device Measurement Equivalency | 1007 activity counts | Standard Deviation 989 |
Secondary
Association of Device Recordings to Clinical Events
Device recordings were assessed and compared to clinical events in both the healthy group and arrhythmia monitoring group. Device recording associations were assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Population: Devices in all subjects were assessed for arrythmia/symptom associations. The healthy and arrhthmia monitoring groups were combined for this outcome measure as the study investigated whether documented symptoms were associated with ECG arrhythmia regardless of group allocation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Front Position Devices | Association of Device Recordings to Clinical Events | 5 Arrhythmias associated with symptoms |
Secondary
Device Recording Stability
Device recording stability was assessed through the heart rate coefficient of variation in both front and side placed devices. Stability was assessed irrespective of whether the device was being worn in Period 1 or Period 2.
Time frame: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
Population: Includes both healthy and arrhythmia monitoring groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Front Position Devices | Device Recording Stability | 0.48 Percent Coefficient of Variation | Standard Deviation 0.47 |
| Side Position Devices | Device Recording Stability | 0.41 Percent Coefficient of Variation | Standard Deviation 0.2 |
Secondary
Respiration Rate Front and Side Device Measurement Equivalency
Respiration rates were compared between front and side placed devices. The outcome was measured only during Period 1 when both front and side devices were worn simultaneously.
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Population: Includes both healthy and arrhythmia monitoring groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Front Position Devices | Respiration Rate Front and Side Device Measurement Equivalency | 16.9 respirations per minute | Standard Deviation 4.4 |
| Side Position Devices | Respiration Rate Front and Side Device Measurement Equivalency | 16.9 respirations per minute | Standard Deviation 4.4 |
Secondary
Sleep Angle Front and Side Device Measurement Equivalency
Sleep angle was compared between front and side devices.
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Population: Includes both healthy and arrhythmia monitoring groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Front Position Devices | Sleep Angle Front and Side Device Measurement Equivalency | 2.5 degrees | Standard Deviation 12.8 |
| Side Position Devices | Sleep Angle Front and Side Device Measurement Equivalency | 2.3 degrees | Standard Deviation 12.2 |
Secondary
Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency
The TFC measurement was compared between front and side placed devices. TFC is a unitless measurement that encompasses the degree of reflected radar waves in the lung taken by the study device. Higher TFC is indicative of increased fluid, whereas lower TFC is indicative of decreased fluid.
Time frame: Period 1: Start of device wear at Day 0 to Day 7
Population: Includes both healthy and arrhythmia monitoring groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Front Position Devices | Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency | 23.4 units | Standard Deviation 7.3 |
| Side Position Devices | Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency | 24.0 units | Standard Deviation 9.5 |