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Handheld ECG Tracking of In-hOspital Atrial Fibrillation

NCT03197090 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2021-10-22

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Zenicor ECG

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

Sponsors & Collaborators

  • Stéphane Cook, Prof

    lead OTHER

Principal Investigators

  • Stéphane P Cook, MD · University of Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2019-08-31
Completion
2019-09-01

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03197090 on ClinicalTrials.gov