Handheld ECG Tracking of In-hOspital Atrial Fibrillation

Study Overview
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Brief Summary
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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

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Zenicor ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the internal medicine department of the University and Hospital Fribourg throughout the study period will be screened for study enrollment. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zenicor ON<br>Patients allocated to the experimental group will undergo systematic short ECG monitoring | Device: Zenicor ECG<br>* Participants will place their thumbs on the device twice daily and whenever they notice palpitations.<br>|
| No Intervention: Zenicor OFF<br>In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newly detected in-hospital AF | Proportion of newly detected atrial fibrillation. | During hospitalizaion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Zenicor