ECG MonitoringSEERSNCT06896734

mobiCARE™ ECG Monitoring System

An observational study of ECG Monitoring, run by Seers Technology Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ECG Monitoring
What is being tested?: Evaluation of the ECG signal in the nominal location and in three alternate positions
Type of treatment: Medical device
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2025to 16 Mar 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

Male and female adults ≥ 18 years of age;
Willing and able to provide informed consent;
Able to speak and read English fluently;
Participant is ambulatory.

Who cannot join

Patients with cardiac pacemaker;
Patients with cardioverter defibrillator;
Patients with other implantable electric devices;
Currently or has a medical history of skin cancer, rash, skin disorder, keloid, and/or any injury in the chest area;
Patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient;
Patients with known history of life-threatening arrhythmias;

Show all 10Show fewer

Use in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI;
Patients with neuro-stimulator, as it may disrupt the quality of ECG data;
Critical care patients;
Chest pain at the time of presentation for the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910

Other trials in United States

About this study

Official title: Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study

Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study

Read the 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.

Conditions: ECG Monitoring
Being tested: Evaluation of the ECG signal in the nominal location and in three alternate positions
Keywords: ECG, Heart Rhythm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evaluation of the ECG signal in the nominal location and in three alternate positionsDevice
Evaluation of the ECG signal in the nominal location and in three alternate positions to determine if the three alternate positions are interpretable.

Study groups in NCT06896734
Study group	Role	What they receive
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. Receives: Device: Evaluation of the ECG signal in the nominal location and in three alternate positions

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 minutes while the patient ambulates

Secondary outcomes (4)

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).
Measured: 2 minutes
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.
Measured: 2 Minutes
Human Factors Evaluation Measures
Usability Performance Evaluation for Health Care Professionals and Subjects
Measured: 2 Minutes
The Number of Measurable Positions for P-waves
Informational data collected to evaluate interpretability based on P-wave amplitude
Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202516 Mar 2025

First posted26 Mar 2025
Study start1 Jan 2025
Primary completion5 Feb 2025
Study completion16 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for ECG MonitoringStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06896734
Sponsor's protocol ID: SEER-CLIN-2024-01
Acronym: SEERS
Status last verified: Apr 2025
First submitted: 28 Feb 2025
Last updated: 9 May 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kim C, Kim SH, Suh MR. Accuracy and Validity of Commercial Smart Bands for Heart Rate Measurements During Cardiopulmonary Exercise Test. Ann Rehabil Med. 2022 Aug;46(4):209-218. doi: 10.5535/arm.22050. Epub 2022 Aug 31.
PubMed 36071003
Rosol M, Petelczyc M, Gasior JS, Mlynczak M. Prediction of peak oxygen consumption using cardiorespiratory parameters from warmup and submaximal stage of treadmill cardiopulmonary exercise test. PLoS One. 2024 Jan 10;19(1):e0291706. doi: 10.1371/journal.pone.0291706. eCollection 2024.
PubMed 38198496
The Prediction of oxygen consumption during Cardiopulmonary exercise test using Wearable ECG (54th Annual Meeting of the Korean Society of Cardiovascular and Thoracic Surgeons 2022 (Alpensia Resort, Pyeongchang, Korea), 2022.11.03-05
Kwon S, Choi EK, Lee SR, Oh S, Song HS, Lee YS, Han SJ, Lim HE. Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System. Korean Circ J. 2024 Mar;54(3):140-153. doi: 10.4070/kcj.2023.0252.
PubMed 38506104
Lee KH, Kim YR, Yoon NS et al. Prediction of Atrial Fibrillation with Single-Lead Mobile ECG during Normal Sinus Rhythm using Deep Learning. e-Cardiology/Digital Health, Public Health, Health Economics, Research Methodology - e-Cardiology/Digital Health, Artificial Intelligence (Machine Learning, Deep Learning. 2024;26 (Supplement 1).
Ahn HJ, Choi EK, Lee SR, Kwon S, Song HS, Lee YS, Oh S. Three-Day Monitoring of Adhesive Single-Lead Electrocardiogram Patch for Premature Ventricular Complex: Prospective Study for Diagnosis Validation and Evaluation of Burden Fluctuation. J Med Internet Res. 2024 Mar 21;26:e46098. doi: 10.2196/46098.
PubMed 38512332
Lee HA, Yu W, Choi JD, Lee YS, Park JW, Jung YJ, Sheen SS, Jung J, Haam S, Kim SH, Park JE. Development of Machine Learning Model for VO2max Estimation Using a Patch-Type Single-Lead ECG Monitoring Device in Lung Resection Candidates. Healthcare (Basel). 2023 Oct 30;11(21):2863. doi: 10.3390/healthcare11212863.
PubMed 37958007
Kwon S, Lee SR, Choi EK, Ahn HJ, Song HS, Lee YS, Oh S, Lip GYH. Comparison Between the 24-hour Holter Test and 72-hour Single-Lead Electrocardiogram Monitoring With an Adhesive Patch-Type Device for Atrial Fibrillation Detection: Prospective Cohort Study. J Med Internet Res. 2022 May 9;24(5):e37970. doi: 10.2196/37970.
PubMed 35532989
Kwon S, Lee SR, Choi EK, Ahn HJ, Song HS, Lee YS, Oh S. Validation of Adhesive Single-Lead ECG Device Compared with Holter Monitoring among Non-Atrial Fibrillation Patients. Sensors (Basel). 2021 Apr 30;21(9):3122. doi: 10.3390/s21093122.
PubMed 33946269
Walsh JA 3rd, Topol EJ, Steinhubl SR. Novel wireless devices for cardiac monitoring. Circulation. 2014 Aug 12;130(7):573-81. doi: 10.1161/CIRCULATIONAHA.114.009024. No abstract available.
PubMed 25114186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ECG Monitoring trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study
ClinicalTrials.gov ID: NCT06896734
Acronym / sponsor ID: SEERS / SEER-CLIN-2024-01
Conditions: ECG Monitoring
Keywords: ECG, Heart Rhythm
Study type: Observational
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Seers Technology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Eminence Clinical Research, Inc.
Study start: 1 Jan 2025 (actual)
Primary completion: 5 Feb 2025 (actual)
Study completion: 16 Mar 2025 (actual)
First posted: 26 Mar 2025 (actual)
Results: Posted 9 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
The study population will include adults who are asymptomatic or who may suffer from transient sympt	–	Device: Evaluation of the ECG signal in the nominal location and in three alternate positionsThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

Male and female adults ≥ 18 years of age;
Willing and able to provide informed consent;
Able to speak and read English fluently;
Participant is ambulatory.

Key exclusion criteria (10 listed)

Patients with cardiac pacemaker;
Patients with cardioverter defibrillator;
Patients with other implantable electric devices;
Currently or has a medical history of skin cancer, rash, skin disorder, keloid, and/or any injury in the chest area;
Patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Evaluation of the ECG signal in the nominal location and in three alternate positionsEvaluation of the ECG signal in the nominal location and in three alternate positions to determine if the three alternate positions are interpretable.	Device	The study population will include adults who are asymptomatic or who may suffer from transient sympt

Primary outcome

Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions
Time frame: 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.

4 secondary outcomes

Presence of Artifact Graded
Time frame: 2 minutes
Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions
Time frame: 2 Minutes
Human Factors Evaluation Measures
Time frame: 2 Minutes
The Number of Measurable Positions for P-waves
Time frame: 2 minutes

Results and safety

Results posted to the registry on 9 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mobiCARE™ ECG Monitoring System Subjects	49	49

Primary outcome: Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions

Time frame: 2 minutes while the patient ambulates. Count of participants. Unit: Participants

Measure	Nominal Location n = 49	Alternate Position 1 n = 49	Alternate Position 2 n = 49	Alternate Position 3 n = 49
Value	49	49	49	49

Population analysed: Primary Effectiveness Evaluation: Difference in Interpretability of ECG Signal for MobiCARE™ Nominal and Three Alternative Electrode Placement Locations

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 Minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Events	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36071003Kim C, Kim SH, Suh MR. Accuracy and Validity of Commercial Smart Bands for Heart Rate Measurements During Cardiopulmonary Exercise Test. Ann Rehabil Med. 2022 Aug;46(4):209-218. doi: 10.5535/arm.22050. Epub 2022 Aug 31.
Background: PubMed 38198496Rosol M, Petelczyc M, Gasior JS, Mlynczak M. Prediction of peak oxygen consumption using cardiorespiratory parameters from warmup and submaximal stage of treadmill cardiopulmonary exercise test. PLoS One. 2024 Jan 10;19(1):e0291706. doi: 10.1371/journal.pone.0291706. eCollection 2024.
BackgroundThe Prediction of oxygen consumption during Cardiopulmonary exercise test using Wearable ECG (54th Annual Meeting of the Korean Society of Cardiovascular and Thoracic Surgeons 2022 (Alpensia Resort, Pyeongchang, Korea), 2022.11.03-05
Background: PubMed 38506104Kwon S, Choi EK, Lee SR, Oh S, Song HS, Lee YS, Han SJ, Lim HE. Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System. Korean Circ J. 2024 Mar;54(3):140-153. doi: 10.4070/kcj.2023.0252.
BackgroundLee KH, Kim YR, Yoon NS et al. Prediction of Atrial Fibrillation with Single-Lead Mobile ECG during Normal Sinus Rhythm using Deep Learning. e-Cardiology/Digital Health, Public Health, Health Economics, Research Methodology - e-Cardiology/Digital Health, Artificial Intelligence (Machine Learning, Deep Learning. 2024;26 (Supplement 1).
Background: PubMed 38512332Ahn HJ, Choi EK, Lee SR, Kwon S, Song HS, Lee YS, Oh S. Three-Day Monitoring of Adhesive Single-Lead Electrocardiogram Patch for Premature Ventricular Complex: Prospective Study for Diagnosis Validation and Evaluation of Burden Fluctuation. J Med Internet Res. 2024 Mar 21;26:e46098. doi: 10.2196/46098.
Background: PubMed 37958007Lee HA, Yu W, Choi JD, Lee YS, Park JW, Jung YJ, Sheen SS, Jung J, Haam S, Kim SH, Park JE. Development of Machine Learning Model for VO2max Estimation Using a Patch-Type Single-Lead ECG Monitoring Device in Lung Resection Candidates. Healthcare (Basel). 2023 Oct 30;11(21):2863. doi: 10.3390/healthcare11212863.
Background: PubMed 35532989Kwon S, Lee SR, Choi EK, Ahn HJ, Song HS, Lee YS, Oh S, Lip GYH. Comparison Between the 24-hour Holter Test and 72-hour Single-Lead Electrocardiogram Monitoring With an Adhesive Patch-Type Device for Atrial Fibrillation Detection: Prospective Cohort Study. J Med Internet Res. 2022 May 9;24(5):e37970. doi: 10.2196/37970.
Background: PubMed 33946269Kwon S, Lee SR, Choi EK, Ahn HJ, Song HS, Lee YS, Oh S. Validation of Adhesive Single-Lead ECG Device Compared with Holter Monitoring among Non-Atrial Fibrillation Patients. Sensors (Basel). 2021 Apr 30;21(9):3122. doi: 10.3390/s21093122.
Background: PubMed 25114186Walsh JA 3rd, Topol EJ, Steinhubl SR. Novel wireless devices for cardiac monitoring. Circulation. 2014 Aug 12;130(7):573-81. doi: 10.1161/CIRCULATIONAHA.114.009024. No abstract available.
Individual participant dataSharing planned: No

Related trials for ECG Monitoring

Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
Aortic Valve Disease, Conduction Disturbances
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingObservational study
Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable
Monitoring, ECG
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of ECG Monitoring, run by Seers Technology Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions (time frame: 2 minutes while the patient ambulates). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06896734, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.