NCT07158333已完成不适用
Mobile Cardiac Telemetry (MCT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cumulative wear time
研究概览
简要总结
This study will be a single center, single arm, open-label, prospective study to evaluate adhesive performance of the Bardy Diagnostics' (BardyDx) MCT Patch up to 30 days of wear.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Each subject must meet the following criteria to be enrolled in this study:
- •Subject is ≥18 years of age.
- •Completes the consent process as required.
- •Subject can speak and read English fluently.
- •Subject is willing to allow shaving of device application area, as required.
- •Subject is willing and able to take photos of the application area before, during, and immediately after wear of each Adhesive Patch
排除标准
- •Unable to comply with the study protocol and instructions for wearing the MCT Patch for up to 30 days.
- •Geographically located such that they cannot have the initial MCT Patch placed by PI or designee.
- •Any breached or compromised skin, skin rash, irritation or infection over the sternum (prior to the initial application) as reported by the subject and/or observed by the PI during initial application.
- •Had any sternal incision or wound within 3 months prior to the date of enrolment.
- •Subjects with sensitive skin or known skin conditions, including known allergies.
- •Subjects with scheduled cardioversion during the data collection period.
- •Subjects with a scheduled electronic imaging (including magnetic resonance imaging) during the data collection period.
- •Subject has known cardiac arrhythmia conditions (Note: The PI will assess the subject during initial screening. If an arrhythmia is discovered during the subject will be deemed ineligible for participation in the study).
结局指标
主要结局
Cumulative wear time
时间窗: 30 days
as measured by ECG readability sufficient for identification of the P and QRS waves; the total readable duration summed from each patch, measured from the start of the first day to the end
次要结局
- Subject Self-Reported Log & Subject Survey of the MCT Patch after 30 days(30 days)
- Adverse events of relevance, including potential skin damage due to repeated removal and reapplication of the MCT Patch as determined by Investigator/designee from subject assessments including Subject Logs, Subject Surveys and photos.(From enrollment to end of study at 30 days.)
研究者
研究点 (1)
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