Conventional Lead Opposed to Novel ECG
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
To blindly assess, beat-by-beat, standard ECG intervals (QRS intervals, PQ intervals, and P wave durations) of paired standard lead v4 with paired HeartWatch signals over 20 to 30 seconds of noise-free data.
详细描述
This proof-of-concept study will enroll volunteers undergoing serial conventional 12-lead ECG rhythm strips who agree to wear a HeartWatch and use a Kardia mobile during those recordings.
The HeartWatch data will not be used for clinical decision-making. Rhythm strips from conventional 12-lead ECG recordings and the HeartWatch recordings will be obtained in volunteers in supine and standing positions and with the device placed in the recommended and in non-recommended positions (i.e., internally and externally rotated in keeping with the observed malposition identified in human factors testing environments (one inch or 2.5 cm; HelpWear, data on file).
Rhythm strips from serial 10-sec, 12-lead recordings will be obtained to allow for beat-by-beat comparisons of ECG intervals over the 20 to 30 seconds of noise free data. Specifically, the intervals from continuous v4 beats with paired continuous HeartWatch beats and the intervals from continuous lead I beats with paired continuous Kardia beats.
Since the HeartWatch is not intended to be used for evaluation of the ST segment or the QT interval, the comparison of the HeartWatch to standard lead v4 will exclude QT assessment.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 22 years of age at time of the conventional ECG recording
- •Willing to participate in the study
- •Able to follow the protocol
排除标准
- •Known allergy to the electrodes used for a conventional ECG
- •Known allergy to any component of the HeartWatch
- •Known allergy to any component of the Kardia system
- •Inability to wear the HeartWatch on the left arm due to pre-existing medical condition (e.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot or recurrent blood clots in left arm, chronic neuropathic pain in left arm, …)
- •Dextrocardia
- •Implanted functional Pacemaker of Defibrillator
- •Left upper arm circumference < 22 cm or > 45 cm
研究组 & 干预措施
Healthy volunteers
Volunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording.
干预措施: ECG signals collection (Device)