mobiCARE™ ECG Monitoring System

NCT06896734 | Completed Results

• 1 other identifier: SEER-CLIN-2024-01
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ECG Monitoring

Keywords

ECG; Heart Rhythm

Outcome Measures

Primary Outcomes (1)

• 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.

  2 minutes while the patient ambulates

Secondary Outcomes (4)

• Presence of Artifact Graded

  2 minutes

• Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions

  2 Minutes

• Human Factors Evaluation Measures

  2 Minutes

• The Number of Measurable Positions for P-waves

  2 minutes

Study Arms (1)

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.

Device: Evaluation of the ECG signal in the nominal location and in three alternate positions

Interventions

Evaluation of the ECG signal in the nominal location and in three alternate positions DEVICE

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

The study population will include adults who are asymptomatic or who may suffer from transient sympt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Seers Technology Co., Ltd.: lead
• Eminence Clinical Research, Inc.: collaborator

Study Sites (1)

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Related Publications (10)

• 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.

  PMID: 36071003 BACKGROUND

• 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.

  PMID: 38198496 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 38506104 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 38512332 BACKGROUND

• 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.

  PMID: 37958007 BACKGROUND

• 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.

  PMID: 35532989 BACKGROUND

• 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.

  PMID: 33946269 BACKGROUND

• 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.

  PMID: 25114186 BACKGROUND

Results Point of Contact

• Title: Nick Leppo
• Organization: Eminence Clinical Research, Inc.

nleppo@ecr-inc.com

719-400-7464

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 26, 2025
• Study Start: January 1, 2025
• Primary Completion: February 5, 2025
• Study Completion: March 16, 2025
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)