试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 5
- 主要终点
- Diagnostic Sensitivity
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's subcutaneous cardiac rhythm monitor for the detection of AF prior to an ablation procedure.
详细描述
BIO-Precision is a post-market study investigating the utility of atrial fibrillation (AF) detection using BIOTRONIK's subcutaneous cardiac rhythm monitor, BIOMONITOR. The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's BIOMONITOR for the detection and confirmation of AF prior to an ablation procedure. Study population includes patients with paroxysmal AF being evaluated for an AF ablation. Holter monitoring for 48 hours will be performed after insertion of the BIOMONITOR but prior to AF ablation. This study will enroll up to 100 subjects, to obtain 60 usable Holter recordings, at 5 study sites within the United States (U.S.). Study subjects will be followed for three months after the completion of a 48 hr Holter monitor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the indications for subcutaneous cardiac rhythm monitor insertion according to local regulations
- •Patient is able to understand the nature of the study and provide written informed consent
- •Inserted within the prior 30 days, or scheduled for insertion within 14 days, with BIOTRONIK's most current subcutaneous cardiac rhythm monitor
- •Diagnosed with paroxysmal atrial fibrillation and being evaluated for an AF ablation
- •Agree to wearing a 48 hr Holter monitor
- •Able and willing to complete all study visits at the study site for the study duration
- •Able and willing to use a CardioMessenger® and accepts Home Monitoring concept
- •Age greater than or equal to 18 years
排除标准
- •Patient meets none of the indications for a BIOMONITOR
- •Patient is planned to have an ablation prior to BIOMONITOR insertion or 48 hr Holter monitoring visit
- •Patient is currently diagnosed with long-standing persistent or permanent AF
- •Patient is enrolled in another study that may change or alter the cardiac rhythm that occurs prior to the completion of the Holter
- •Currently indicated for or implanted with a pacemaker, ICD device, or hemodynamic monitoring system
- •Life expectancy less than 6 months
- •Patients reporting pregnancy at the time of enrollment
- •For patients enrolled after BIOMONITOR insertion:
- •R-wave sensing <0.25 mV according to the most recent remote or in-person device interrogation available prior to enrollment
- •After the pre-Holter observation period but prior to 48 hr Holter monitoring initiation, confirm the absence of the following exclusion criteria based on the remote interrogation collected at the end of the observation period:
- •No AF episodes observed or transmitted during pre-Holter observation period
- •R-wave sensing <0.25 mV during pre-Holter observation period as reported by the 24 hr mean or mean value since last follow-up
结局指标
主要结局
Diagnostic Sensitivity
时间窗: 48 hours
The diagnostic sensitivity of the BIOMONITOR will be determined by comparing AF events detected by the BIOMONITOR and 48 hr Holter monitor for each subject. Diagnostic sensitivity is the ability of the BIOMONITOR to correctly identify subjects who have true AF as determined by the Holter monitor. It is calculated as the number of participants with a true BIOMONITOR AF detection divided by the sum of the number of participants with a true BIOMONITOR AF detection and the number of participants with a false negative BIOMONITOR AF detection.
次要结局
未报告次要终点