Multi-Channel Esophageal ECG Signal Classification

NCT02541175 | Completed

• 1 other identifier: 149/15
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to prove new methods to enable the automated analysis of esophageal electrocardiography (eECG) signals in long-term measurements as well as the detection of atrial fibrillation. The investigators hypothesis is that eECG signals allow the reliable atrial and ventricular ECG signal distinction and the detection of atrial fibrillation. Therefore 14 patients with arrhythmias and 6 cardiac healthy subjects are asked to take part in this study. On each subject an esophageal ECG and a simultaneous standard surface ECG will be taken for about half an hour. Patient undergoing a cardiac catheter ablation during their current hospitalization will be further asked to allow access to the invasively obtained measurements (i.e. atrial potential map) to further improve the understanding of the eECG signals.

Conditions

Atrial Fibrillation; Atrial Function; Arrhythmias, Cardiac; Atrial Premature Complexes

Keywords

Electrocardiography; Automation; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Atrial Premature Complexes; Esophagus

Outcome Measures

Primary Outcomes (1)

• Number of correct classified A/V beats in automated eECG analysis compared to manually analyzed surface ECG

  during analysis of ECG (approx. 30 minutes records)

Secondary Outcomes (1)

• Number of correctly detected atrial fibrillation sequences in automated eECG analysis compared to manually analyzed surface ECG

  during analysis of ECG (approx. 30 minutes records)

Study Arms (1)

All study participants

In order to cover a wide variety of common arrhythmias but keeping the number of subjects needed low (pilot study), the subjects are pre-selected according to following 4 categories: 1) 4 patients with intermitting or persisting atrial fibrillation. 2) 4 patients with atrial flutter 3) 6 patients with frequent atrial or ventricular extra-systoles. 4) 6 cardiac healthy subjects.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients: Adults, hospitalised at University Hospital Bern, Dept. of Cardiology. Healthy subjects: Adults without any assumed or known cardiac disease.

You may qualify if:

• Age \>/= 18 years
• Written informed consent
• ambulatory/hospitalized due to peripheral percutaneous intervention
• ambulatory/hospitalized due to shunt stenosis or occlusion
• ambulatory/hospitalized due to electrophysiological intervention
• ambulatory/hospitalized due to pacemaker implantation
• ambulatory/hospitalized due to decompensated heart failure
• ambulatory/hospitalized due to planed cardioangiography
• ambulatory/hospitalized due to performed cardioangiography after Non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI)
• cardiac healthy adults

You may not qualify if:

• History of ablation of atrial fibrillation
• History of heart transplantation
• Instable angina pectoris/acute myocardial infarction before revascularisation
• Cardiorespiratory unstable patients
• History of valve replacement operation less than 4 weeks ago
• Obstructive cardiomyopathy with severe dynamic Left Ventricular Outflow Tract (LVOT) obstruction
• Known severe bleeding diathesis
• Known malformations or disease in the upper airways, conflicting with the catheter insertion
• Known malformations or disease in the esophagus, conflicting with the catheter insertion
• Uncontrolled arterial hypertonia (syst. blood pressure \> 200mmHg)
• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Bern University of Applied Sciences: collaborator

Study Sites (1)

Dept. of Cardiology, University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (5)

• Haeberlin A, Niederhauser T, Marisa T, Goette J, Jacoment M, Mattle D, Roten L, Fuhrer J, Tanner H, Vogel R. The optimal lead insertion depth for esophageal ECG recordings with respect to atrial signal quality. J Electrocardiol. 2013 Mar-Apr;46(2):158-65. doi: 10.1016/j.jelectrocard.2012.12.004. Epub 2013 Jan 8.

  PMID: 23305907 BACKGROUND

• Haeberlin A, Niederhauser T, Tanner H, Vogel R. Atrial waveform analysis using esophageal long-term electrocardiography reveals atrial ectopic activity. Clin Res Cardiol. 2012 Nov;101(11):941-2. doi: 10.1007/s00392-012-0477-6. Epub 2012 May 22. No abstract available.

  PMID: 22614730 BACKGROUND

• Haeberlin A, Roten L, Schilling M, Scarcia F, Niederhauser T, Vogel R, Fuhrer J, Tanner H. Software-based detection of atrial fibrillation in long-term ECGs. Heart Rhythm. 2014 Jun;11(6):933-8. doi: 10.1016/j.hrthm.2014.03.014. Epub 2014 Mar 12.

  PMID: 24632179 BACKGROUND

• Wallmann D, Tuller D, Wustmann K, Meier P, Isenegger J, Arnold M, Mattle HP, Delacretaz E. Frequent atrial premature beats predict paroxysmal atrial fibrillation in stroke patients: an opportunity for a new diagnostic strategy. Stroke. 2007 Aug;38(8):2292-4. doi: 10.1161/STROKEAHA.107.485110. Epub 2007 Jun 21.

  PMID: 17585079 BACKGROUND

• Wildhaber RA, Bruegger D, Zalmai N, Malmberg H, Goette J, Jacomet M, Tanner H, Haeberlin A, Loeliger HA. Estimation of the Cardiac Field in the Esophagus Using a Multipolar Esophageal Catheter. IEEE Trans Biomed Circuits Syst. 2018 Aug;12(4):791-800. doi: 10.1109/TBCAS.2018.2817027. Epub 2018 May 7.

  PMID: 29993892 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Premature Complexes; Atrial Flutter

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease

Study Officials

• Hildegard Tanner, Prof. Dr. med.

  Dept. of Cardiology, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 4, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

CH (1)