Handheld ECG Tracking of In-hOspital Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— HECTO-AF  

Official title:

Handheld ECG Tracking of In-hOspital Atrial Fibrillation - The HECTO-AF Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03197090
• Other study ID #: HECTO-AF Trial
• Status: Terminated
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: April 2020
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 804
• Est. completion date: September 1, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Zenicor ECG
Participants will place their thumbs on the device twice daily and whenever they notice palpitations.

Locations

Country	Name	City	State
Switzerland	University and hospital of Fribourg	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
Stéphane Cook, Prof

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newly detected in-hospital AF	Proportion of newly detected atrial fibrillation.	During hospitalizaion