Handheld ECG Tracking of In-hOspital Atrial Fibrillation (HECTO-AF)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Zenicor ECG
Sponsored by
About this trial
This is an interventional screening trial for Atrial Fibrillation focused on measuring Screening, Zenicor
Eligibility 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.
Sites / Locations
- University and hospital of Fribourg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Zenicor ON
Zenicor OFF
Arm Description
Patients allocated to the experimental group will undergo systematic short ECG monitoring
In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines.
Outcomes
Primary Outcome Measures
Newly detected in-hospital AF
Proportion of newly detected atrial fibrillation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03197090
Brief Title
Handheld ECG Tracking of In-hOspital Atrial Fibrillation
Acronym
HECTO-AF
Official Title
Handheld ECG Tracking of In-hOspital Atrial Fibrillation - The HECTO-AF Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
poor patient recruitment and limited resources
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stéphane Cook, Prof
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Screening, Zenicor
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
804 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zenicor ON
Arm Type
Experimental
Arm Description
Patients allocated to the experimental group will undergo systematic short ECG monitoring
Arm Title
Zenicor OFF
Arm Type
No Intervention
Arm Description
In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines.
Intervention Type
Device
Intervention Name(s)
Zenicor ECG
Intervention Description
Participants will place their thumbs on the device twice daily and whenever they notice palpitations.
Primary Outcome Measure Information:
Title
Newly detected in-hospital AF
Description
Proportion of newly detected atrial fibrillation.
Time Frame
During hospitalizaion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane P Cook, MD
Organizational Affiliation
University of Freiburg
Official's Role
Study Chair
Facility Information:
Facility Name
University and hospital of Fribourg
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25910800
Citation
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.
Results Reference
background
PubMed Identifier
22922413
Citation
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. Erratum In: Eur Heart J. 2013 Mar;34(10):790. Eur Heart J. 2013 Sep;34(36):2850-1.
Results Reference
background
PubMed Identifier
22236222
Citation
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. Erratum In: N Engl J Med. 2016 Mar 10;374(10):998.
Results Reference
background
PubMed Identifier
34017869
Citation
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.
Results Reference
derived
PubMed Identifier
30700332
Citation
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.
Results Reference
derived
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Handheld ECG Tracking of In-hOspital Atrial Fibrillation
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