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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| Front Position Devices | All devices placed in the front position | ||
| Side Position Devices | All devices placed in the side position |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| µCor | Device | Sensor Monitor for arrhythmia and other bio-metric markers |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
| 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. | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
| 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. | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
| Device Data Transmission and Device Connectivity | Count of subjects that had daily data transmission. | Period 1 and Period 2 |
| 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. | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
| Documentation of Clinically Actionable Events. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Period 1: Start of device wear at Day 0 to Day 7 |
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-Inclusion Criteria
The following criteria will be used to include subjects in phase I portion of the study:
The following criteria will be used to include subjects in phase II portion of the study:
The following criteria will be used to exclude subjects from phases I and II portions of the study:
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Healthy adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring.
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| Name | Affiliation | Role |
|---|---|---|
| Mike Osz | Zoll Medical Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Hochschule Hannover | Hanover | Germany |
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An additional subject was enrolled beyond the protocol in the arrhythmia group.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Within 7 Days From Start of Device Wear |
| |||||||||||||||||||
| Between 7th and 90th Day of Device Wear |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Arrhythmia Monitoring Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | count of participants | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
|
Adverse events were collected from enrollment of the subject in the study to the date the subject completed the study, up to 90 days.
Adverse evenst were defined in the study as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects, users, or other persons whether or not related to the study device.
Serious adverse events were defined per study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mike Osz | ZOLL Medical Corporation | 4129683333 | 14104 | mosz@zoll.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2018 | Nov 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
| 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. | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
| 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. | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
| 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. | Period 1: Start of device wear at Day 0 to Day 7 |
| Activity Front and Side Device Measurement Equivalency | Activity counts were compared between front and side devices. | Period 1: Start of device wear at Day 0 to Day 7 |
| Sleep Angle Front and Side Device Measurement Equivalency | Sleep angle was compared between front and side devices. | Period 1: Start of device wear at Day 0 to Day 7 |
| Wore Front Position Device |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Devices placed in the side position
|
|
| 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. | Devices on subjects in the arrythmia group that were allocated for 90 day wear were used in the assessment. | Posted | Mean | Standard Deviation | Days | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
|
|
|
| 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. | A position assessment and orientation placement was assessed for accuracy for all front and side devices. | Posted | Number | percentage of correct placements | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
|
|
|
| Primary | Device Data Transmission and Device Connectivity | Count of subjects that had daily data transmission. | Posted | Number | count of participants | Period 1 and Period 2 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | hours | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
|
|
|
| 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. | Posted | Number | documented clinical events | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
|
|
|
| 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. | Includes both healthy and arrhythmia monitoring groups | Posted | Mean | Standard Deviation | units | Period 1: Start of device wear at Day 0 to Day 7 |
|
|
|
| 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. | 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. | Posted | Number | Arrhythmias associated with symptoms | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
|
|
|
| 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. | Includes both healthy and arrhythmia monitoring groups | Posted | Mean | Standard Deviation | Percent Coefficient of Variation | Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90 |
|
|
|
| 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. | Includes both healthy and arrhythmia monitoring groups | Posted | Mean | Standard Deviation | respirations per minute | Period 1: Start of device wear at Day 0 to Day 7 |
|
|
|
| Secondary | Activity Front and Side Device Measurement Equivalency | Activity counts were compared between front and side devices. | Includes both healthy and arrhythmia monitoring groups | Posted | Mean | Standard Deviation | activity counts | Period 1: Start of device wear at Day 0 to Day 7 |
|
|
|
| Secondary | Sleep Angle Front and Side Device Measurement Equivalency | Sleep angle was compared between front and side devices. | Includes both healthy and arrhythmia monitoring groups | Posted | Mean | Standard Deviation | degrees | Period 1: Start of device wear at Day 0 to Day 7 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | 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 | 0 | 45 | 0 | 45 | 42 | 45 |
Any proposed publication relating to the research conducted under this protocol will be submitted to the sponsor for review at least 45 days prior to submission for publication. The publication may be delayed for an additional period of up to 90 days for intellectual property considerations or until all confidential information has been eliminated from the publication(s) and sponsor has approved the publication. It may be determined by the sponsor that no data from this study will be published.