Handheld ECG Tracking of In-hOspital Atrial Fibrillation (HECTO-AF)

Stéphane Cook, Prof

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Device: Zenicor ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT03197090

HECTO-AF Trial

Details and patient eligibility

About

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

Enrollment: 804 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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804 participants in 2 patient groups

Zenicor ON

Experimental group

Description:

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

Treatment:

Device: Zenicor ECG

Zenicor OFF

No Intervention group

Description:

In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines.