mobiCARE™ ECG Monitoring System (SEERS)

Seers Technology

Status: Completed

Conditions: ECG Monitoring

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06896734

SEER-CLIN-2024-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

49 participants in 1 patient group

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

Description:

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.

Treatment:

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