NCT06041373撤回不适用
Verily Watch Cardio (AF and ECG) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Sensitivity and Specificity of suspected AF episode detection
研究概览
简要总结
This study is designed to evaluate the performance of the Verily Watch Cardio for recording electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial fibrillation (AF) episodes, in a free-living environment, in participants at risk for having an AF event.
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
- •At least 22 years old
- •Able to read and speak English
- •Participant understands the study requirements and is able and willing to sign written Informed Consent
- •At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one or more of the following:
- •Scheduled or to be scheduled to undergo AF ablation
- •AF burden of ≥25% in the 3 months prior to consent date as confirmed via an implantable loop recorder (ILR), holter monitor, or adhesive monitoring patch
- •CHA2DS2VASc score ≥3
- •Left atrial diameter ≥4.4 cm as confirmed by transthoracic echo (TTE) within one year of consent
- •Without significant limitation in ability to participate in the study, in the opinion of the Investigator
排除标准
- •Have a pacemaker or implantable cardioverter defibrillator (ICD)
- •Currently on class Ic or class III antiarrhythmic medication that has been successful in eliminating AF (no documented AF of more than 30 seconds since the initiation of the medication). Should be at least one week off medication.
- •Had successful AF ablation (no documented AF of more than 30 seconds post procedure)
- •Known severe allergy to nickel or metal jewelry
- •Known allergic reaction to polyester, nylon, spandex, adhesives or hydrogels; or with family history of adhesive skin allergies
- •Are diagnosed with persistent AF
- •Have an implantable neuro-stimulator
- •Currently wearing an ECG patch that prevents the use of the FDA-cleared wearable ECG patch, at the discretion of the Investigator.
- •Have discolored wrists (e.g., tattoos, ink), at the discretion of the Investigator.
结局指标
主要结局
Sensitivity and Specificity of suspected AF episode detection
时间窗: Up to 14 days
Sensitivity and Specificity of suspected AF episode detection by the irregular pulse detection algorithm
次要结局
- Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA)(Up to 14 days)
- Participant-level and heartbeat level sensitivity/specificity of P-wave detection(Up to 14 days)
- A sensitivity analysis estimating the range of sensitivities and specificities(Up to 14 days)
- Sensitivity and Specificity in defined subgroups(Up to 14 days)
研究者
研究点 (3)
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