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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03197090
Recruitment Status : Terminated (poor patient recruitment and limited resources)
First Posted : June 23, 2017
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Stéphane Cook, Prof, University of Freiburg

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


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Zenicor ECG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 804 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Handheld ECG Tracking of In-hOspital Atrial Fibrillation - The HECTO-AF Trial
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zenicor ON
Patients allocated to the experimental group will undergo systematic short ECG monitoring
Device: Zenicor ECG
Participants will place their thumbs on the device twice daily and whenever they notice palpitations.

No Intervention: Zenicor OFF
In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines.



Primary Outcome Measures :
  1. Newly detected in-hospital AF [ Time Frame: During hospitalizaion ]
    Proportion of newly detected atrial fibrillation.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197090


Locations
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Switzerland
University and hospital of Fribourg
Fribourg, Switzerland, 1708
Sponsors and Collaborators
Stéphane Cook, Prof
Investigators
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Study Chair: Stéphane P Cook, MD University of Freiburg
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stéphane Cook, Prof, Sponsor-Investigator, University of Freiburg
ClinicalTrials.gov Identifier: NCT03197090    
Other Study ID Numbers: HECTO-AF Trial
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stéphane Cook, Prof, University of Freiburg:
Screening
Zenicor
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes