跳至主要内容
临床试验/NCT03197090
NCT03197090终止不适用

Handheld ECG Tracking of In-hOspital Atrial Fibrillation - The HECTO-AF Trial

Stéphane Cook, Prof1 个研究点 分布在 1 个国家目标入组 804 人开始时间: 2018年3月9日最近更新:
适应症
干预措施

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

Experimental

Patients allocated to the experimental group will undergo systematic short ECG monitoring

干预措施: Zenicor ECG (Device)

Zenicor OFF

No Intervention

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

发起方
Stéphane Cook, Prof
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stéphane Cook, Prof

Sponsor-Investigator

University of Freiburg

研究点 (1)

Loading locations...

相似试验