Handheld ECG Tracking of In-hOspital Atrial Fibrillation

NCT03197090 | Terminated

• 1 other identifier: HECTO-AF Trial
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Keywords

Screening; Zenicor

Outcome Measures

Primary Outcomes (1)

• Newly detected in-hospital AF

  Proportion of newly detected atrial fibrillation.

  During hospitalizaion

Study Arms (2)

Zenicor ON

EXPERIMENTAL

Patients allocated to the experimental group will undergo systematic short ECG monitoring

Device: Zenicor ECG

Zenicor OFF

NO INTERVENTION

In patients allocated to the control group, usual diagnostic procedures for detection of atrial fibrillation will be employed according to ESC Guidlines.

Interventions

Zenicor ECG DEVICE

Participants will place their thumbs on the device twice daily and whenever they notice palpitations.

Zenicor ON

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the internal medicine department of the University and Hospital Fribourg throughout the study period will be screened for study enrollment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stéphane Cook, Prof: lead

Study Sites (1)

University and hospital of Fribourg

Fribourg, 1708, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 25910800 BACKGROUND

• 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.

  PMID: 22922413 BACKGROUND

• 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.

  PMID: 22236222 BACKGROUND

• 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.

  PMID: 34017869 DERIVED

• 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.

  PMID: 30700332 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane P Cook, MD

  University of Freiburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: June 23, 2017
• Study Start: March 9, 2018
• Primary Completion: August 31, 2019
• Study Completion: September 1, 2019
• Last Updated: October 22, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)