ECG Monitoring
Conditions
Keywords
ECG, Heart Rhythm
Brief summary
Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study
Detailed description
The purpose of the Seers Technology Company Ltd. sponsored study using the mobiCARE™ ECG Monitoring System is to document the variability and interpretability of heart rhythm tracings from the nominal position whereby the mobiCARE™ device is still able to obtain interpretable ECG signals, in a cohort of adults representative of the U.S. population. Informational data will be collected, such as P-wave amplitude and QRS amplitude and duration to note any morphological ECG signal changes. Human factors (HF) endpoints will be evaluated including: HCP placement according to IFU, subject demonstration of changing electrodes, dexterity for user to perform the task, electrode placement according to skin markings, and the ability of the user to remove and replace the mobiCARE™ device.
Interventions
DEVICEEvaluation of the ECG signal in the nominal location and in three alternate positions
Evaluation of the ECG signal in the nominal location and in three alternate positions to determine if the three alternate positions are interpretable.
Sponsors
Eminence Clinical Research, Inc.
Seers Technology Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female adults ≥ 18 years of age; 2. Willing and able to provide informed consent; 3. Able to speak and read English fluently; 4. Participant is ambulatory.
Exclusion criteria
1. Patients with cardiac pacemaker; 2. Patients with cardioverter defibrillator; 3. Patients with other implantable electric devices; 4. Currently or has a medical history of skin cancer, rash, skin disorder, keloid, and/or any injury in the chest area; 5. Patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient; 6. Patients with known history of life-threatening arrhythmias; 7. Use in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI; 8. Patients with neuro-stimulator, as it may disrupt the quality of ECG data; 9. Critical care patients; 10. Chest pain at the time of presentation for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions | 2 minutes while the patient ambulates | Evaluation of the ECG signal at the nominal location and in up to three (3) additional alternate positions (AP) in each subject to determine if the signal is interpretable. The term interpretable is defined as follows: An independent cardiologist reader is able to identify the ECG rhythm in each location when compared to the ECG rhythm measured in the nominal position of the mobiCARE™ Cardiac Monitoring System described in the Instructions for Use. ECG rhythm data will be collected for up to two (2) minutes while the patient ambulates. ECG rhythm data were collected in each location during normal use for at least two (2) minutes while the subject was sitting, standing, and ambulating. The simultaneous Holter Monitor will be measured at the same time points to have a point of reference for the mobiCARE™ system in the case that changes in the rhythm are noted on the mobiCARE™ Cardiac Monitoring System during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Artifact Graded | 2 minutes | Presence of artifact graded as 1=none, 2=minor (cardiac rhythm is interpretable), or 3=major (cardiac rhythm is not interpretable by the independent cardiologist). |
| Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions | 2 Minutes | The number of measurable positions for QRS amplitude and QRS duration at the nominal position and up to 3 alternate positions. |
| Human Factors Evaluation Measures | 2 Minutes | Usability Performance Evaluation for Health Care Professionals and Subjects |
| The Number of Measurable Positions for P-waves | 2 minutes | Informational data collected to evaluate interpretability based on P-wave amplitude |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The Study Population Will Include Adults Who Are Asymptomatic or Who May Suffer From Transient Sympt The study population will include adults who are asymptomatic or who may suffer from transient symptoms such as arrhythmias and/or palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety; ranging in age, ethnic group, BMI, educational level and gender.
Evaluation of the ECG signal in the nominal location and in three alternate positions: Evaluation of the ECG signal in the nominal location and in three alternate positions to determine if the three alternate positions are interpretable. | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | The Study Population Will Include Adults Who Are Asymptomatic or Who May Suffer From Transient Sympt |
|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 18.6 |
| Race/Ethnicity, Customized Race/ Ethnicity African American | 8 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity Asian / Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity Caucasian / non-Hispanic | 26 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity Hispanic | 9 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity Native American/Native Alaskan | 4 Participants |
| Region of Enrollment United States | 49 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions
Evaluation of the ECG signal at the nominal location and in up to three (3) additional alternate positions (AP) in each subject to determine if the signal is interpretable. The term interpretable is defined as follows: An independent cardiologist reader is able to identify the ECG rhythm in each location when compared to the ECG rhythm measured in the nominal position of the mobiCARE™ Cardiac Monitoring System described in the Instructions for Use. ECG rhythm data will be collected for up to two (2) minutes while the patient ambulates. ECG rhythm data were collected in each location during normal use for at least two (2) minutes while the subject was sitting, standing, and ambulating. The simultaneous Holter Monitor will be measured at the same time points to have a point of reference for the mobiCARE™ system in the case that changes in the rhythm are noted on the mobiCARE™ Cardiac Monitoring System during the study.
Time frame: 2 minutes while the patient ambulates
Population: Primary Effectiveness Evaluation: Difference in Interpretability of ECG Signal for MobiCARE™ Nominal and Three Alternative Electrode Placement Locations
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nominal Location | Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions | 49 Participants |
| Alternate Position 1 | Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions | 49 Participants |
| Alternate Position 2 | Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions | 49 Participants |
| Alternate Position 3 | Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions | 49 Participants |
Secondary
Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions
The number of measurable positions for QRS amplitude and QRS duration at the nominal position and up to 3 alternate positions.
Time frame: 2 Minutes
Population: All 49 subjects had measurable QRS complexes in the nominal position and in all three alternate positions, AP #1, AP #2, and AP #3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nominal Location | Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions | 49 Participants |
| Alternate Position 1 | Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions | 49 Participants |
| Alternate Position 2 | Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions | 49 Participants |
| Alternate Position 3 | Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions | 49 Participants |
Secondary
Human Factors Evaluation Measures
Usability Performance Evaluation for Health Care Professionals and Subjects
Time frame: 2 Minutes
Population: 15 subjects were planned for human factors data collection. 49 subjects were observed for collection of human factors data. The scores for each assessment range from 1 (Difficult) to 5 (Easy). The Healthcare Professional (HCP) and Subject usabilty results are summarized below by mean and standard deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nominal Location | Human Factors Evaluation Measures | How easy/difficult for the HCP to place device/electrodes in the Nominal Location using the IFU? | 3.94 units on a scale | Standard Deviation 0.92 |
| Nominal Location | Human Factors Evaluation Measures | Could the HCP read the ECG signal on app to confirm Lead II/clear signal after the device placed? | 4.43 units on a scale | Standard Deviation 0.74 |
| Nominal Location | Human Factors Evaluation Measures | How easy/difficult for subject to remove the device/electrodes from Alternate location 3? | 4.1 units on a scale | Standard Deviation 1.01 |
| Nominal Location | Human Factors Evaluation Measures | How easy or difficult was it for the subject to remove the used electrodes from the mobiCARE™? | 3.67 units on a scale | Standard Deviation 1.13 |
| Nominal Location | Human Factors Evaluation Measures | How easy/difficult for subject to replace electrodes with new electrodes on the mobiCARE™ device? | 3.69 units on a scale | Standard Deviation 1.29 |
| Nominal Location | Human Factors Evaluation Measures | How easy or difficult was it for the subject to locate the markings for the nominal position? | 3.49 units on a scale | Standard Deviation 1.23 |
| Nominal Location | Human Factors Evaluation Measures | How easy/difficult for subject to replace new mobiCARE™ device (electrodes) in the Nominal position | 3.78 units on a scale | Standard Deviation 1.23 |
Secondary
Presence of Artifact Graded
Presence of artifact graded as 1=none, 2=minor (cardiac rhythm is interpretable), or 3=major (cardiac rhythm is not interpretable by the independent cardiologist).
Time frame: 2 minutes
Population: Artifact was rated by the independent ECG reader and rated as 0, 1, or 2. To reflect a more detailed assessment, category 1 was divided into two scores, 1A and 1B. The artifact was categorized according to the definitions below:~0 = None to negligible artifact~1A = Minor amount of artifact (≤50% of ECG has artifact); ECG is interpretable~1. B = Major amount of artifact (\>50% of ECG has artifact); ECG is interpretable~2. = Major (\>50% of ECG has artifact); ECG is NOT interpretable.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nominal Location | Presence of Artifact Graded | 2 Major - = Major (>50% of ECG has artifact); ECG is NOT interpretable. | 0 Participants |
| Nominal Location | Presence of Artifact Graded | 1B Major - Major amount of artifact (>50% of ECG has artifact); ECG is interpretable | 5 Participants |
| Nominal Location | Presence of Artifact Graded | 1A Minor - Minor amount of artifact (≤50% of ECG has artifact); ECG is interpretable | 9 Participants |
| Nominal Location | Presence of Artifact Graded | None = 0 - None to negligible artifact | 35 Participants |
| Alternate Position 1 | Presence of Artifact Graded | 1A Minor - Minor amount of artifact (≤50% of ECG has artifact); ECG is interpretable | 14 Participants |
| Alternate Position 1 | Presence of Artifact Graded | 1B Major - Major amount of artifact (>50% of ECG has artifact); ECG is interpretable | 14 Participants |
| Alternate Position 1 | Presence of Artifact Graded | None = 0 - None to negligible artifact | 21 Participants |
| Alternate Position 1 | Presence of Artifact Graded | 2 Major - = Major (>50% of ECG has artifact); ECG is NOT interpretable. | 0 Participants |
| Alternate Position 2 | Presence of Artifact Graded | None = 0 - None to negligible artifact | 28 Participants |
| Alternate Position 2 | Presence of Artifact Graded | 1A Minor - Minor amount of artifact (≤50% of ECG has artifact); ECG is interpretable | 11 Participants |
| Alternate Position 2 | Presence of Artifact Graded | 1B Major - Major amount of artifact (>50% of ECG has artifact); ECG is interpretable | 10 Participants |
| Alternate Position 2 | Presence of Artifact Graded | 2 Major - = Major (>50% of ECG has artifact); ECG is NOT interpretable. | 0 Participants |
| Alternate Position 3 | Presence of Artifact Graded | None = 0 - None to negligible artifact | 31 Participants |
| Alternate Position 3 | Presence of Artifact Graded | 2 Major - = Major (>50% of ECG has artifact); ECG is NOT interpretable. | 0 Participants |
| Alternate Position 3 | Presence of Artifact Graded | 1A Minor - Minor amount of artifact (≤50% of ECG has artifact); ECG is interpretable | 11 Participants |
| Alternate Position 3 | Presence of Artifact Graded | 1B Major - Major amount of artifact (>50% of ECG has artifact); ECG is interpretable | 7 Participants |
Secondary
The Number of Measurable Positions for P-waves
Informational data collected to evaluate interpretability based on P-wave amplitude
Time frame: 2 minutes
Population: 48 subjects in normal sinus rhythm with measurable P-waves. One subject didn't have a measurable P-wave due to atrial fibrillation. Data is consistent as reported with 48/49 subjects having measurable P-waves.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nominal Location | The Number of Measurable Positions for P-waves | 48 Participants |
| Alternate Position 1 | The Number of Measurable Positions for P-waves | 48 Participants |
| Alternate Position 2 | The Number of Measurable Positions for P-waves | 48 Participants |
| Alternate Position 3 | The Number of Measurable Positions for P-waves | 48 Participants |