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Handheld ECG Tracking of In-hOspital Atrial Fibrillation

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03197090
Acronym
HECTO-AF
Enrollment
804
Registered
2017-06-23
Start date
2018-03-09
Completion date
2019-09-01
Last updated
2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Screening, Zenicor

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

Interventions

DEVICEZenicor ECG

Participants will place their thumbs on the device twice daily and whenever they notice palpitations.

Sponsors

Stéphane Cook, Prof
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Newly detected in-hospital AFDuring hospitalizaionProportion of newly detected atrial fibrillation.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026