Conventional Lead Opposed to Novel ECG (CLONE) (CLONE)
Conventional Lead Opposed to Novel ECG
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Alberta
-
Calgary、Alberta、加拿大、T2N 1N4
- University Of Calgary
-
Calgary、Alberta、加拿大、T2N 4N1
- University Of Calgary
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- At least 22 years of age at time of the conventional ECG recording
- Willing to participate in the study
- Able to follow the protocol
Exclusion Criteria
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
A Health-Canada and FDA-approved 12-lead ECG system (GE Healthcare, MAC 5500 or equivalent) will be used to collect the 10-sec digital rhythm strips in the noted supine and standing positions. A total of twenty-four (24) recordings, four from each of position, will be collected from each consenting participant:
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Standard ECG and HeartWatch interval duration assessment in standard position
大体时间：The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection testing visit.
|
The three co-primary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a supine position with the HeartWatch in the standard location.
|
The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection testing visit.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional positions.
大体时间：The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit.
|
Secondary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a:
|
The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
12 Lead ECG and Kardia signal duration analysis from supine and standing positions
大体时间：The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit.
|
Exploratory endpoints for this study, for comparative purposes, are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (Kardia system vs. lead I of a standard 12-lead ECG) in supine and standing positions.
|
The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit.
|
|
Device related adverse events.
大体时间：Adverse events will be collected and assessed from all data collection visits immediately following every data collection visit. All adverse events will be followed until resolved or for up to 30 days after the event.
|
The safety endpoint for this study is the incidence of device-related adverse events.
|
Adverse events will be collected and assessed from all data collection visits immediately following every data collection visit. All adverse events will be followed until resolved or for up to 30 days after the event.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CLONE Version 1.0
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.