Conditions

ECG Monitoring

Keywords

ECGHeart 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 positionsDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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;

Sponsors & Collaborators

Seers Technology Co., Ltd.
Industrylead
Eminence Clinical Research, Inc.
Industrycollaborator

Study Sites (1)

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

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: 36071003BACKGROUND
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: 38198496BACKGROUND

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

mobiCARE™ ECG Monitoring System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations