Atrial Fibrillation Algorithms Clinical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apple Inc.
- 入组人数
- 573
- 试验地点
- 8
- 主要终点
- WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]
研究概览
简要总结
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
详细描述
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Able to read, understand, and provide written informed consent
- •Willing and able to participate in the study procedures as described in the consent form
- •Be 22 years of age and older
- •Able to communicate effectively with and follow instructions from the study staff
- •Able to wear the wrist device for duration of study participation
- •For Cohort 1, have no known medical history of AF
- •For Cohort 2, have no known medical history of AF and active diagnosis of at least one of the following arrhythmias within the past 2 years:
- •Frequent PACs, defined as at least 1% of total beats of atrial ectopic beats by 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder)
- •Frequent PVCs, defined as at least 1% of total beats of ventricular ectopic beats by 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder
- •SVT, which will include atrial tachycardia, atrioventricular nodal re-entrant tachycardia, atrioventricular re-entrant tachycardia by 12-lead ECG or 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder
- •NSVT, defined as three or more consecutive ventricular beats at a rate of at least 100 beats per minute and lasting no more than 30 seconds, by 12-lead ECG or 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder
- •For Cohorts 3 and 4, have a known diagnosis of AF at the time of screening (confirmed by electronic medical record (EMR) or self-report) and have had a recent episode of AF, or confirmed AF on ECG, in the past 12 months
- •For Cohort 4, have a known diagnosis of permanent AF at the time of screening (confirmed by EMR or self-report) and have had a recent episode of AF, or confirmed AF on ECG, in the past 12 months
- •Meet additional binning based on demographics.
排除标准
- •Physical disability that precludes safe and adequate testing
- •Mental impairment resulting in limited ability to cooperate
- •Known uncontrolled medical conditions, such as (but not limited to) significant anemia, important electrolyte imbalance and untreated or uncontrolled thyroid disease
- •Open wound(s) on the wrist and/or forearm
- •Tattoos, large moles, or scars on the wrist at the wrist device location
- •Skin conditions on either wrist that would preclude subject from wearing a wristband on either wrist
- •Known allergy or sensitivity to medical adhesives, isopropyl alcohol, wristbands, or ECG patch
- •Medical history or physical assessment finding that makes the subject inappropriate for participation according to investigator(s)
- •Participation in a previous study that used a wrist-worn sensor device with a simultaneous ECG reference patch
- •Implantable cardiac devices such as a Pacemaker or Implantable Cardioverter Defibrillator
- •Clinically significant hand tremors, as judged by the investigator
- •Acute illness including COVID and other respiratory illnesses
- •Subjects with known history of AF on rhythm control medications with history of complete AF rhythm control (i.e history of zero AF burden) will be excluded from Cohorts 3 and 4
结局指标
主要结局
WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]
时间窗: 13 DAYS
Weekly AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during wrist device wear over the prior 7 consecutive days. The weekly AF burden was estimated by both the reference device and the algorithm and reported using the Bland-Altman limits of Agreement.
SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
时间窗: 13 DAYS
Sensitivity of the irregular rhythm notification for the identification of persons with AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Sensitivity is defined as the percentage of subjects exhibiting AF on the ambulatory ECG who also received an irregular rhythm notification concordant with at least one episode of AF.
SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF]
时间窗: 13 DAYS
Specificity of the lack of irregular rhythm notification for the identification of persons without AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Specificity is defined as the percentage of subjects not exhibiting AF on the ambulatory ECG who also did not receive any irregular rhythm notifications.
次要结局
- TACHOGRAM SPECIFICITY [IRNF](13 DAYS)
- TACHOGRAM FALSE POSITIVE RATE [IRNF](13 DAYS)
- TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF](13 DAYS)
- FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF](13 DAYS)
- TACHOGRAM SENSITIVITY [IRNF](13 DAYS)
- TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF](13 DAYS)
- TACHOGRAM ALERT SENSITIVITY [IRNF](13 DAYS)
- TACHOGRAM ALERT SPECIFICITY [IRNF](13 DAYS)
- Tachogram Alert False Positive Rate [IRNF](13 DAYS)
- Tachogram Alert Negative Predictive Value [IRNF](13 DAYS)
- TACHOGRAM SENSITIVITY [AFBF](13 days)
- TACHOGRAM SPECIFICITY [AFBF](13 days)
- TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF](13 days)
- TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF](13 days)
- POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF](13 DAYS)
- Tachogram Alert Positive Predictive Value [IRNF](13 DAYS)
- DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF](13 DAYS)