N/A
Completed N=49
mobiCARE™ ECG Monitoring System
ECG Monitoring
Source: ClinicalTrials.gov NCT06896734 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions — 49; 49; 49; 49 Participants
Summary
Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions |
49; 49; 49; 49 | — |
| SECONDARY Presence of Artifact Graded |
35; 21; 28; 31; 9; 14 | — |
| SECONDARY Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions |
49; 49; 49; 49 | — |
| SECONDARY Human Factors Evaluation Measures |
3.94; 4.43; 4.1; 3.67; 3.69; 3.49 | — |
| SECONDARY The Number of Measurable Positions for P-waves |
48; 48; 48; 48 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06896734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.