Feasibility and Usability of a Chest-Strap Ambulatory ECG Monitor in Active Individuals in Comparison With a Traditional Ambulatory ECG Patch Monitor (MoMe ARC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Total Time in Atrial Fibrillation Detected by Frontier X Plus and MoMe ARC
研究概览
简要总结
The purpose of this research is to compare the standard ambulatory ECG monitor, the MoMe ARC, against Fourth Frontier's "Frontier X Plus". This device is an FDA-Cleared chest-strap-based ECG wearable that provides an alternative modality to capture ambulatory ECG rhythm changes.
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
- 否
入选标准
- •Adult participants (>22 years; Frontier X is approved for use in this age group) who participate in >4 days a week of >150 minutes total per week of moderate to high intensity exercise who were prescribed a ambulatory ECG monitor for clinical purposes for 24 hours or more.
- •Patients must agree to wear the Frontier X monitor for the prescribed duration and use the Frontier X Plus application
排除标准
- •Current use of Implanted Cardiac Devices
- •Pregnancy
- •Known allergies to any of the materials listed in the "List of Patient-Contacting Materials"
- •Presence of skin injuries or broken skin in the area where the chest strap is worn
- •Inability to use a compatible mobile device required for the operation of the study device
- •Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures
- •Medical restrictions on exercise for safety including cardiac, orthopedic or other relevant past medical history
研究组 & 干预措施
Active Adults Undergoing Ambulatory ECG Monitoring
Participants prescribed clinical ambulatory ECG monitoring will wear the Frontier X Plus chest-strap ECG device simultaneously with the MoMe ARC traditional ambulatory ECG monitor during their prescribed monitoring period and typical daily activities, including exercise.
干预措施: Frontier X Plus chest-strap ECG device (Device)
Active Adults Undergoing Ambulatory ECG Monitoring
Participants prescribed clinical ambulatory ECG monitoring will wear the Frontier X Plus chest-strap ECG device simultaneously with the MoMe ARC traditional ambulatory ECG monitor during their prescribed monitoring period and typical daily activities, including exercise.
干预措施: MoMe ARC ambulatory ECG monitor (Device)
结局指标
主要结局
Total Time in Atrial Fibrillation Detected by Frontier X Plus and MoMe ARC
时间窗: 24 hours
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Total time in atrial fibrillation will be assessed for each device and reported as the cumulative duration of atrial fibrillation detected during the concordant monitoring period.
Concordance of Symptomatic Triggered Events Between Frontier X Plus and MoMe ARC
时间窗: 24 hours
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for symptomatic triggered events. Results will be reported as the number of symptomatic triggered event findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
Concordance of Ventricular Tachycardia Episodes Greater Than 3 Beats Detected by Frontier X Plus and MoMe ARC
时间窗: 24 hours
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for ventricular tachycardia episodes greater than 3 beats. Results will be reported as the number of ventricular tachycardia episode findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
Concordance of Supraventricular Tachycardia Episodes Greater Than 3 Beats Between Frontier X Plus and MoMe ARC
时间窗: 24 hours
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for supraventricular tachycardia episodes greater than 3 beats. Results will be reported as the number of supraventricular tachycardia episode findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
Concordance of Premature Atrial Contraction Counts Between Frontier X Plus and MoMe ARC
时间窗: 24 hours
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for premature atrial contraction counts. Results will be reported as the number of premature atrial contraction count findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
Concordance of Premature Ventricular Contraction Counts Between Frontier X Plus and MoMe ARC
时间窗: 24 hours
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Concordance will be assessed for premature ventricular contraction counts. Results will be reported as the number of premature ventricular contraction count findings for which the Frontier X Plus and MoMe ARC reports are in agreement.
Atrial Fibrillation Burden Detected by Frontier X Plus and MoMe ARC
时间窗: 24 hours
Automated Holter-style reports generated from the Frontier X Plus device will be compared with MoMe ARC reports. Atrial fibrillation burden will be assessed for each device and reported as the percentage of the concordant monitoring period during which atrial fibrillation was detected.
次要结局
未报告次要终点
研究者
Elizabeth H. Dineen
Principal Investigator
Mayo Clinic