Handheld ECG Tracking of In-hOspital Atrial Fibrillation (HECTO-AF)
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|ClinicalTrials.gov Identifier: NCT03197090|
Recruitment Status : Terminated (poor patient recruitment and limited resources)
First Posted : June 23, 2017
Last Update Posted : April 27, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Zenicor ECG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||804 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Handheld ECG Tracking of In-hOspital Atrial Fibrillation - The HECTO-AF Trial|
|Actual Study Start Date :||March 9, 2018|
|Actual Primary Completion Date :||August 31, 2019|
|Actual Study Completion Date :||September 1, 2019|
Experimental: Zenicor ON
Patients allocated to the experimental group will undergo systematic short ECG monitoring
Device: Zenicor ECG
Participants will place their thumbs on the device twice daily and whenever they notice palpitations.
No Intervention: Zenicor OFF
In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines.
- Newly detected in-hospital AF [ Time Frame: During hospitalizaion ]Proportion of newly detected atrial fibrillation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197090
|University and hospital of Fribourg|
|Fribourg, Switzerland, 1708|
|Study Chair:||Stéphane P Cook, MD||University of Freiburg|