Clinical trial NCT06896734: mobiCARE™ ECG Monitoring System
Official title: Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ECG Monitoring
Keywords: ECG
Heart Rhythm
Lead sponsor: Seers Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Eminence Clinical Research, Inc.
First posted: 2025-03-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions
timeFrame: 2 minutes while the patient ambulates
Secondary outcomes:
measure: Presence of Artifact Graded
timeFrame: 2 minutes
measure: Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions
timeFrame: 2 Minutes
measure: Human Factors Evaluation Measures
timeFrame: 2 Minutes
measure: The Number of Measurable Positions for P-waves
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
Study officials:
References:
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