Trial Outcomes & Findings for mobiCARE™ ECG Monitoring System (NCT NCT06896734)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

49 participants

Primary outcome timeframe

2 minutes while the patient ambulates

Results posted on

2025-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	mobiCARE™ ECG Monitoring System Subjects 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.
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

mobiCARE™ ECG Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Study Population Will Include Adults Who Are Asymptomatic or Who May Suffer From Transient Sympt n=49 Participants 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.
Age, Continuous	40 years STANDARD_DEVIATION 18.6 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race/Ethnicity, Customized Race/ Ethnicity · Caucasian / non-Hispanic	26 Participants n=5 Participants
Race/Ethnicity, Customized Race/ Ethnicity · African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Race/ Ethnicity · Asian / Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/ Ethnicity · Hispanic	9 Participants n=5 Participants
Race/Ethnicity, Customized Race/ Ethnicity · Native American/Native Alaskan	4 Participants n=5 Participants
Region of Enrollment United States	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Nominal Location n=49 Participants 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: Evaluation of the ECG signal in the nominal location to determine if the three alternate positions are interpretable.	Alternate Position 1 n=49 Participants 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 alternate position 1 location: Evaluation of the ECG signal in the alternate position 1 to determine if the three alternate positions are interpretable.	Alternate Position 2 n=49 Participants 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 alternate position 2 location: Evaluation of the ECG signal in the alternate position 2 to determine if the three alternate positions are interpretable.	Alternate Position 3 n=49 Participants 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 alternate position 3 location: Evaluation of the ECG signal in the alternate position 3 to determine if the three alternate positions are interpretable.
Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions	49 Participants	49 Participants	49 Participants	49 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Nominal Location n=49 Participants 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: Evaluation of the ECG signal in the nominal location to determine if the three alternate positions are interpretable.	Alternate Position 1 n=49 Participants 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 alternate position 1 location: Evaluation of the ECG signal in the alternate position 1 to determine if the three alternate positions are interpretable.	Alternate Position 2 n=49 Participants 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 alternate position 2 location: Evaluation of the ECG signal in the alternate position 2 to determine if the three alternate positions are interpretable.	Alternate Position 3 n=49 Participants 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 alternate position 3 location: Evaluation of the ECG signal in the alternate position 3 to determine if the three alternate positions are interpretable.
Presence of Artifact Graded None = 0 - None to negligible artifact	35 Participants	21 Participants	28 Participants	31 Participants
Presence of Artifact Graded 1A Minor - Minor amount of artifact (≤50% of ECG has artifact); ECG is interpretable	9 Participants	14 Participants	11 Participants	11 Participants
Presence of Artifact Graded 1B Major - Major amount of artifact (>50% of ECG has artifact); ECG is interpretable	5 Participants	14 Participants	10 Participants	7 Participants
Presence of Artifact Graded 2 Major - = Major (>50% of ECG has artifact); ECG is NOT interpretable.	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

The number of measurable positions for QRS amplitude and QRS duration at the nominal position and up to 3 alternate positions.

Outcome measures

Outcome measures
Measure	Nominal Location n=49 Participants 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: Evaluation of the ECG signal in the nominal location to determine if the three alternate positions are interpretable.	Alternate Position 1 n=49 Participants 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 alternate position 1 location: Evaluation of the ECG signal in the alternate position 1 to determine if the three alternate positions are interpretable.	Alternate Position 2 n=49 Participants 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 alternate position 2 location: Evaluation of the ECG signal in the alternate position 2 to determine if the three alternate positions are interpretable.	Alternate Position 3 n=49 Participants 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 alternate position 3 location: Evaluation of the ECG signal in the alternate position 3 to determine if the three alternate positions are interpretable.
Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions	49 Participants	49 Participants	49 Participants	49 Participants

SECONDARY outcome

Timeframe: 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.

Usability Performance Evaluation for Health Care Professionals and Subjects

Outcome measures

Outcome measures
Measure	Nominal Location n=49 Participants 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: Evaluation of the ECG signal in the nominal location to determine if the three alternate positions are interpretable.	Alternate Position 1 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 alternate position 1 location: Evaluation of the ECG signal in the alternate position 1 to determine if the three alternate positions are interpretable.	Alternate Position 2 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 alternate position 2 location: Evaluation of the ECG signal in the alternate position 2 to determine if the three alternate positions are interpretable.	Alternate Position 3 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 alternate position 3 location: Evaluation of the ECG signal in the alternate position 3 to determine if the three alternate positions are interpretable.
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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	—	—	—
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 outcome

Timeframe: 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.

Informational data collected to evaluate interpretability based on P-wave amplitude

Outcome measures

Outcome measures
Measure	Nominal Location n=49 Participants 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: Evaluation of the ECG signal in the nominal location to determine if the three alternate positions are interpretable.	Alternate Position 1 n=49 Participants 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 alternate position 1 location: Evaluation of the ECG signal in the alternate position 1 to determine if the three alternate positions are interpretable.	Alternate Position 2 n=49 Participants 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 alternate position 2 location: Evaluation of the ECG signal in the alternate position 2 to determine if the three alternate positions are interpretable.	Alternate Position 3 n=49 Participants 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 alternate position 3 location: Evaluation of the ECG signal in the alternate position 3 to determine if the three alternate positions are interpretable.
The Number of Measurable Positions for P-waves	48 Participants	48 Participants	48 Participants	48 Participants

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nick Leppo

Eminence Clinical Research, Inc.

Phone: 719-400-7464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place