Confirm Implantable Cardiac Monitor Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 18
- 主要终点
- Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
研究概览
简要总结
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias
- •Patients who experience transient symptoms that may suggest a cardiac arrhythmia
- •Patients who have been previously diagnosed with atrial fibrillation
- •Patients who are suspected to have Atrial Fibrillation (AF) but AF has not been documented
- •Patients who have provided written informed consent to participate in the study.
排除标准
- •Patients who are under the age of 18 years
- •Patients who have a life expectancy less than 1 year
- •Patients who are unable to comply with the follow-up schedule
- •Patients who are currently implanted with a pacemaker or defibrillator
- •Patients who the physician deems inappropriate for the study
研究组 & 干预措施
Open Label
SJM Confirm Device
干预措施: SJM Confirm (Device)
结局指标
主要结局
Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
时间窗: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers
时间窗: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings at Rest
时间窗: 6 weeks
The sensitivity was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise
时间窗: 6 weeks
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers
时间窗: 6 weeks
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Positive Predictive Value (PPV) for In-Clinic Recordings at Rest
时间窗: 6 weeks
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
次要结局
未报告次要终点