Multi-Channel Esophageal ECG Signal Classification (MC-EECG)

January 12, 2017 updated by: University Hospital Inselspital, Berne

Paroxysmal Atrial Fibrillation Detection and Heart Beat Classification in Multi-Channel Esophageal Long-Term ECG

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Background

The fast and correct diagnosis of heart rhythm disorders is very important to reduce morbidity and mortality in cardiovascular patients. Atrial fibrillation is of special interest, because it is an important cause of devastating brain strokes. A significant number of strokes have a cardioembolic genesis due to paroxysmal atrial fibrillation which was not diagnosed early enough. Therefore, it is very important to detect atrial fibrillation as soon as possible. With oral anticoagulation an effective therapeutic option in available to prevent cardioembolisms.

In the clinical routine, mostly 24-hour or 7-day ECGs are made to look for cardiac arrhythmias. The use of such devices is well established. Nevertheless, they have some side effects/limitations. Skin electrodes used for derivation of the ECG often cause skin irritation, sometimes leading to premature termination of the recording. Because of dryout of the contact gel (causes artifacts), small p-waves and especially also motion artifacts, triggered recording or semi-automatic analysis of the recording is problematic, but for longer recording times such a semi-automatic analysis would be helpful. As an alternative esophageal electrocardiography can be performed. Signal quality of the ECG recording (especially of the left atrium) is better than in the standard surface ECG because of the vicinity of the esophagus and the left atrium. The esophagus tolerates well foreign bodies as the investigators know from long-term nasogastric intubation. Therefore use of the esophageal technique for long-term rhythm monitoring is an interesting and promising alternative to conventional surface Holter ECGs.

Earlier studies have already shown the improved p-wave in eECG signals, but the automatic or semi-automatic wave analysis algorithms were not satisfactory. By increasing the number of measuring channels on the esophageal catheter, new classes of algorithm can be applied in order to increase the detection reliability. Using multiple channels to increase the quality of the result is an intuitive and widely used method e.g. in 12 lead ECG or EECG, etc.

Objective

Primary Objective: Differentiation of electrical atrial and ventricular cardiac activity (A/V classification) Secondary Objective: Detection of atrial fibrillation sequences (AFib Detection)

Methods

20 subjects are included in this pilot study to verify enhanced multi-channel detection algorithm. In order to cover a wide variety of arrhythmias to test the algorithm with, the subjects are selected according to 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. In total around 50'000 heart beats are recorded. The surface ECG signal is used as the reference (manually analyzed). Sensitivity and specificity of the correctly detected atrial and ventricular activities compared to this manual reference including the 95% confidence intervals are calculated (A/V Classification). Additionally the sensitivity and specificity of the detected of atrial fibrillation sequences including the 95% confidence intervals are calculated (AFib Detection).

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Dept. of Cardiology, University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of correct classified A/V beats in automated eECG analysis compared to manually analyzed surface ECG
Time Frame: during analysis of ECG (approx. 30 minutes records)
during analysis of ECG (approx. 30 minutes records)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of correctly detected atrial fibrillation sequences in automated eECG analysis compared to manually analyzed surface ECG
Time Frame: during analysis of ECG (approx. 30 minutes records)
during analysis of ECG (approx. 30 minutes records)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Bern University of Applied Sciences

Investigators

  • Principal Investigator: Hildegard Tanner, Prof. Dr. med., Dept. of Cardiology, University Hospital Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (ESTIMATE)

September 4, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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