HECTO-AF: Handheld ECG Tracking of In-hOspital Atrial Fibrillation

• Sponsor: Stéphane Cook, Prof (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03197090
• Collaborator: (none)
• Enrollment: 804
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.8
• Patients Per Site Per Month: 45.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Zenicor ECG	N/A

Study Design

• Study Type: Interventional
• 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: Mar 9, 2018
• Actual Primary Completion Date: Aug 31, 2019
• Actual Study Completion Date: Sep 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Newly detected in-hospital AF [During hospitalizaion]

   Proportion of newly detected atrial fibrillation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University and hospital of Fribourg	Fribourg		Switzerland	1708

Sponsors and Collaborators

• Stéphane Cook, Prof

Investigators

• Study Chair: Stéphane P Cook, MD, University of Freiburg

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Erratum in: Eur Heart J. 2013 Mar;34(10):790. Eur Heart J. 2013 Sep;34(36):2850-1.
• 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.
• 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.

• Responsible Party: Stéphane Cook, Prof, Sponsor-Investigator, University of Freiburg
• ClinicalTrials.gov Identifier: NCT03197090
• Other Study ID Numbers: HECTO-AF Trial
• First Posted: Jun 23, 2017
• Last Update Posted: Oct 22, 2021
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stéphane Cook, Prof, Sponsor-Investigator, University of Freiburg: Screening; Zenicor
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Oct 22, 2021