Handheld ECG Tracking of In-hOspital Atrial Fibrillation

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Device: Zenicor ECG

• Registration Number: NCT03197090
• Lead Sponsor: Stéphane Cook, Prof

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-10
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Study Start: 2018-03-09
• Primary Completion: 2019-08-31
• Study Completion: 2019-09-01
• Status Verified: 2020-04
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 804

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zenicor ON	Zenicor ECG	Patients allocated to the experimental group will undergo systematic short ECG monitoring

Primary Outcome Measures

Name	Time	Method
Newly detected in-hospital AF	During hospitalizaion	Proportion of newly detected atrial fibrillation.

Trial Locations

Locations (1)

University and hospital of Fribourg; 🇨🇭 Fribourg, Switzerland