Handheld ECG Tracking of In-hOspital Atrial Fibrillation
NCT ID: NCT03197090
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
804 participants
INTERVENTIONAL
2018-03-09
2019-09-01
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Zenicor ON
Patients allocated to the experimental group will undergo systematic short ECG monitoring
Zenicor ECG
Participants will place their thumbs on the device twice daily and whenever they notice palpitations.
Zenicor OFF
In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines.
No interventions assigned to this group
Interventions
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Zenicor ECG
Participants will place their thumbs on the device twice daily and whenever they notice palpitations.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Stéphane Cook, Prof
OTHER
Responsible Party
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Stéphane Cook, Prof
Sponsor-Investigator
Principal Investigators
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Stéphane P Cook, MD
Role: STUDY_CHAIR
University of Freiburg
Locations
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University and hospital of Fribourg
Fribourg, , Switzerland
Countries
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References
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Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.
Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
Mancinetti M, Schukraft S, Faucherre Y, Cook S, Arroyo D, Puricel S. Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial. Front Cardiovasc Med. 2021 May 4;8:681890. doi: 10.3389/fcvm.2021.681890. eCollection 2021.
Schukraft S, Mancinetti M, Hayoz D, Faucherre Y, Cook S, Arroyo D, Puricel S. Handheld ECG Tracking of in-hOspital Atrial Fibrillation The HECTO-AF trial Clinical Study Protocol. Trials. 2019 Jan 30;20(1):92. doi: 10.1186/s13063-019-3189-7.
Other Identifiers
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HECTO-AF Trial
Identifier Type: -
Identifier Source: org_study_id