Multi-phase, Prospective, Multicenter, Non-interventional, Pre-market, Non-randomized, Open-label Study to Evaluate the Clinical Performance of the WHOOP ECG Feature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 6
- 主要终点
- Specificity of the WHOOP ECG Feature for detection of sinus rhythm
研究概览
简要总结
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates.
详细描述
Atrial fibrillation (Afib) is the most common cardiac arrhythmia in the United States, affecting up to one in four individuals across the lifespan, and is associated with substantial morbidity and mortality. Fifteen percent of strokes in the United States are attributable to Afib, and nearly 20% of these occur in individuals with no prior Afib history. Because Afib is often paroxysmal, one-time screening is unlikely to capture those at risk. Thus, there has been an increasing interest in leveraging monitoring for Afib via wearable devices, which provide a novel method to monitor Afib and determine the burden of Afib in the general population.
The primary objective of this study is to assess the sensitivity and specificity of the investigation device (WHOOP ECG Feature) for the detection of Afib as compared to a gold-standard reference (12-Lead ECG Holter Device).
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
- •Aged 22 years or older.
- •Ability to provide informed consent.
- •Willing to participate and to follow the procedures per the Principal Investigator's instructions.
- •Resided in the United States.
- •Wrist circumference: 130 mm to 245 mm at band wear position.
- •Previous medical history of persistent, paroxysmal, or permanent or chronic AF and being in AF at time of enrollment (AF cohort only).
- •No known history of AF and being in normal sinus rhythm at the time of enrollment (NSR cohort only).
排除标准
- •Subjects with an implantable pacemaker device or implantable cardioverter- defibrillator device.
- •Medical history of a life-threatening cardiac arrhythmia, e.g., ventricular tachycardia or fibrillation.
- •Any known allergies to medical adhesives, isopropyl alcohol, or ECG patch.
- •Any known allergy or sensitivity to thermoplastics, metals with physical vapor deposition (PVD) coatings or Elastane used in the wrist fitness devices.
- •Clinically significant body tremors that compromise study measurements.
- •Pregnant at the time of enrollment.
- •Any physical disability that prevents safe and adequate testing.
- •Physical or medical impairments that preclude exercise testing, including, but not limited to, back pain and leg claudication.
- •Mental impairment as determined by the Investigator, or designee.
- •Subjects with any medical history, physical examination finding, vital sign or other finding or assessment that could compromise subject safety, study integrity or accurate assessment of study objectives. This includes, but is not limited to, known untreated medical conditions that may be considered clinically significant, such as significant anemia, electrolyte imbalance, untreated or uncontrolled thyroid disease, and open wound(s) in the area of test band positioning.
- •Vital sign measurements, medical history or physical examination finding that makes the subject inappropriate for participation according to the Investigator.
- •Scarring, tattoos, large, pigmented moles, or other skin pathology in the area of sensor location.
- •Severe skin conditions on either wrist, that would preclude wearing the sensor. Severe symptomatic skin injury, disorder, allergy, or disease such as eczema, rosacea, impetigo, dermatomyositis or contact dermatitis on wrist or other areas where sensors or electrodes would be placed.
- •Clinically significant hand tremors as judged by the Investigator.
- •Participated in phase 1 of the study (Only for phase 2 cohort).
结局指标
主要结局
Specificity of the WHOOP ECG Feature for detection of sinus rhythm
时间窗: 1 Day
Specificity is defined as the True Negatives/(True Negatives + False Positives). A true normal sinus rhythm reading will have a 12-lead ECG reading consistent with normal sinus rhythm. A true negative is defined as individuals who have normal sinus rhythm reported on their ECGs from both the WHOOP ECG Feature and the 12-lead ECG Holter Device. A false positive is defined as individuals who receive an ECG with atrial fibrillation by the WHOOP ECG Feature but their 12-lead ECG has an atrial fibrillation determined by adjudication.
Sensitivity of the WHOOP ECG Feature for detection of atrial fibrillation
时间窗: 1 Day
Sensitivity is defined as the True Positives/(True Positives + False Negatives). A true atrial fibrillation reading will have an 12-lead ECG reading consistent with atrial fibrillation. A true positive is defined as individuals who have atrial fibrillation reported on their WHOOP ECGs and on the 12-lead ECG from the Holter Device. A false negative is defined as individuals who receive an ECG with atrial fibrillation with the 12-lead ECG as determined by adjudication but their WHOOP ECG Feature determination is Normal Sinus Rhythm.
次要结局
未报告次要终点