Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions
研究概览
简要总结
Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions
时间窗: 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.
次要结局
- 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)