Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. 24-48 hour Holter
研究概览
简要总结
This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions. The performance of the wristband in detecting atrial fibrillation and normal sinus rhythms will be compared to a short 12-lead ECG or 24-hour holter.
To ensure that both patients with and without atrial fibrillation are included whilst limiting the burden on patients and hospital staff, four groups of patients are being recruited:
- Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring
- Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation.
- Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF.
- Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.
The secondary outcomes of the study focus on assessing the primary outcomes in light of demographic subgroups, patient physical activity and the signal quality index.
详细描述
Rationale:
Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation. The device has been validated using clinical trials in hospitals, but evaluation in the intended remote setting across various demographic groups is lacking.
Primary objective:
To compare episodes of atrial fibrillation across 30-second intervals detected by the Corsano CardioWatch 287-2 with episodes of atrial fibrillation detected by conventional Holter monitoring across 24-48 hours or short in-clinic 12-lead ECG based on the positive predictive value, negative predictive value, sensitivity and specificity.
Secondary objective: To compare the number of atrial fibrillation episodes greater than 6 minutes, 1 hour, 6 hours, and 12 hours duration detected by the CardioWatch 287-2 and with the number of these specific episodes detected by conventional Holter across 24-48 hours days. As well as to assess primary outcomes in light of demographic subgroups, patient activity and the signal quality index.
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
- •Patients with symptoms indicative of cardiac arrhythmias receiving 24-48 hour ECG holter for home monitoring or in-clinic 12-lead ECG per doctor prescription OR previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation
- •Age ≥ 22 years old
- •Able to provide informed consent.
- •Proficient in written and spoken Dutch or English, defined by self-report of comfort reading, writing, and speaking Dutch or English.
排除标准
- •Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol;
- •Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- •Unable or not willing to receive ECG monitoring;
- •Unable or not willing to sign informed consent;
结局指标
主要结局
Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. 24-48 hour Holter
时间窗: From enrollment up to 48 hours
The absolute number of detected AF 30-second intervals by the CardioWatch's PPG algorithm will be determined and compared to the reference ECG holter monitoring, by means of calculating the positive predictive value (PPV), negative predictive value (NPV), specificity, and sensitivity. Performance goals for PPV and NPV are ≥90%, and performance goals for sensitivity and specificity are ≥95%.
Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. short in-clinic 12-lead ECG
时间窗: From enrollment up to 30 minutes
The absolute number of detected AF 30-second intervals by the CardioWatch's PPG algorithm will be determined and compared to the reference in-clinic 12-lead ECG, by means of calculating the positive predictive value (PPV), negative predictive value (NPV), specificity, and sensitivity. Performance goals for PPV and NPV are ≥90%, and performance goals for sensitivity and specificity are ≥95%.
Atrial fibrillation detection across 30-second intervals by CardioWatch single-lead ECG vs. 24-48 hour Holter
时间窗: From enrollment up to 48 hours
The absolute number of detected AF by the CardioWatch's single-lead ECG algorithm will be determined and compared to the reference ECG holter monitoring at the most similar moment in time by means of calculating the PPV, NPV, specificity, and sensitivity for timestamps corresponding to the single-lead spot checks.
Atrial fibrillation detection across 30-second intervals by CardioWatch single-lead ECG vs. short in-clinic 12-lead ECG
时间窗: From enrollment up to 30 minutes
The absolute number of detected AF by the CardioWatch's single-lead ECG algorithm will be determined and compared to the reference in-clinic ECG at the most similar moment in time by means of calculating the PPV, NPV, specificity, and sensitivity for timestamps corresponding to the single-lead spot checks.
次要结局
- Compliance with ECG alerts(From enrollment up to 48 hours)
- Amount of ECG attempts before successful ECG(From enrollment up to 48 hours)
- Atrial fibrillation detection performance for males vs. females(Baseline information gathered during enrollment)
- Correspondence between cases with AF of greater than 6 minutes, 1 hour, 6 hours, and 12 hours(From enrollment up to 48 hours)
- Confirmation of AF by single-lead ECG(From enrollment up to 48 hours)
- Atrial fibrillation detection performance for BMI subgroups(Baseline information gathered during enrollment)
- Atrial fibrillation detection performance for ethinicity based subgroups(Baseline information gathered during enrollment)
- Atrial fibrillation detection performance in light of patient activity(From enrollment up to 48 hours)
- Atrial fibrillation detection performance in light of signal quality index(From enrollment up to 48 hours)
- RMSE of HR measurement and reference(From enrollment up to 48 hours)
- Atrial fibrillation detection performance for skin colour based subgroups(Baseline information gathered during enrollment)