Handheld ECG Tracking of In-hOspital Atrial Fibrillation - The HECTO-AF Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 804
- 试验地点
- 1
- 主要终点
- Newly detected in-hospital AF
研究概览
简要总结
This is a single center, open label, randomized control trial to assess the efficacy of a one-lead ECG handheld device (Zenicor) for the detection of previously unknown atrial fibrillation (AF) in hospitalized patients.
All patients admitted to the internal medicine department of the Hospital Fribourg throughout the study period will be screened for study enrollment. Patients < 18 years, with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial. The study population will consist of approximately 800 patients in each group at the University of Fribourg Medical Center. Patients must meet all eligibility criteria for inclusion into the study.
Patients allocated to the treatment group will undergo twice daily monitoring with the handheld Zenicor ECG. Additional recordings will be obtained whenever patients notice palpitations. Recordings will be obtained in the presence of specially trained nurses. The recordings will then be validated through a web-based interface offered by Zenicor. The one-lead ECGs will be reviewed by the investigating physicians through the Web-based analysis service (Zenicor-ECG Doctor System) to assess the presence of atrial fibrillation.
The primary end point of the study is the percentage of newly detected atrial fibrillation at 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the internal medicine department of the University and Hospital Fribourg throughout the study period will be screened for study enrollment.
排除标准
- •Patients with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial.
研究组 & 干预措施
Zenicor ON
Patients allocated to the experimental group will undergo systematic short ECG monitoring
干预措施: Zenicor ECG (Device)
Zenicor OFF
In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines.
结局指标
主要结局
Newly detected in-hospital AF
时间窗: During hospitalizaion
Proportion of newly detected atrial fibrillation.
次要结局
未报告次要终点
研究者
Stéphane Cook, Prof
Sponsor-Investigator
University of Freiburg
