NCT02541175|Completed
Multi-Channel Esophageal ECG Signal Classification
MC-EECG
Paroxysmal Atrial Fibrillation Detection and Heart Beat Classification in Multi-Channel Esophageal Long-Term ECG
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MC-EECG
Paroxysmal Atrial Fibrillation Detection and Heart Beat Classification in Multi-Channel Esophageal Long-Term ECG
Sponsor study identifier
observational
20
1 country
1
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 27, 2015
Actual (reported)September 4, 2015
Actual (reported)October 2015
Date type not reportedThis date has not been verified as actual or estimated.
December 2016
Actual (reported)December 2016
Actual (reported)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)
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)
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.
Patients: Adults, hospitalised at University Hospital Bern, Dept. of Cardiology. Healthy subjects: Adults without any assumed or known cardiac disease.
Dept. of Cardiology, University Hospital Bern
Bern, 3010, Switzerland
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.
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.
Hildegard Tanner, Prof. Dr. med.
Dept. of Cardiology, University Hospital Bern
20 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2015
First Posted
September 4, 2015
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Mobile Phone Detection of Atrial Fibrillation
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
January 13, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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