Assert-IQ Insertable Cardiac Monitor Post Market Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 22
- 主要终点
- Episode-based AF detection performance metrics
研究概览
简要总结
This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable Cardiac Monitor (ICM) device.
详细描述
The study's intent is to generate long-term real-world data on the safety, performance, and clinical benefits of the Assert-IQTM ICM device system. This clinical investigation is sponsored by Abbott Medical.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet ALL study inclusion criteria to participate in the study.
- •Have an approved indication AND are scheduled to receive an Assert-IQTM ICM device prior to enrollment in the study.
- •Diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF prior to enrollment in the study and scheduled to undergo a first-time atrial fibrillation ablation.
- •Have a cellular phone or the ability or willing to use a mobile transmitter that is compatible with the myMerlin™ App and able to communicate with the Assert-IQTM ICM device. If a subject doesn't have a cell phone or loses their cell phone, then the site can provide a mobile transmitter to the subject. The study will not provide cell phones.
- •Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
- •Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
排除标准
- •If ANY study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure).
- •Subject is currently participating in another clinical investigation that could confound the results of this study, without documented pre-approval from Abbott.
- •Subject is implanted with a cardiac implantable electronic device (CIED) with pacing capability.
- •Have a life expectancy of less than 1 year due to any condition.
结局指标
主要结局
Episode-based AF detection performance metrics
时间窗: Holter monitor worn by the subjects over a minimum 72-hour and up to 7 days period. An AF episode is defined as AF has greater or equal to 2 minutes (≥2 minutes) in duration.
Episode-based AF detection performance metrics of the Assert-IQTM ICM device compared to that of simultaneous Holter monitoring in 150 subjects who had received the Assert-IQTM ICM device as part of their standard of care.
次要结局
未报告次要终点