Atrial FibrillationMC-EECGNCT02541175
Multi-Channel Esophageal ECG Signal Classification
An observational study of Atrial Fibrillation and Atrial Function, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Function, Arrhythmias, Cardiac
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients: Adults, hospitalised at University Hospital Bern, Dept. of Cardiology. Healthy subjects: Adults without any assumed or known cardiac disease.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. of Cardiology, University Hospital Bern
Bern, 3010
About this study
Official title: 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.
Read the 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).
- Keywords
- Electrocardiography, Automation, Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Atrial Premature Complexes, Esophagus
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Premature Complexes, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of correct classified A/V beats in automated eECG analysis compared to manually analyzed surface ECG
Measured: 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
Measured: during analysis of ECG (approx. 30 minutes records)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Hildegard Tanner, Prof. Dr. med., Principal investigator, Dept. of Cardiology, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541175
- Sponsor's protocol ID
- 149/15
- Acronym
- MC-EECG
- Status last verified
- Jan 2017
- First submitted
- 27 Aug 2015
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23305907Haeberlin 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.
PubMed 22614730Haeberlin 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.
PubMed 24632179Wallmann 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.
PubMed 17585079Wildhaber 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.
PubMed 29993892
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxysmal Atrial Fibrillation Detection and Heart Beat Classification in Multi-Channel Esophageal Long-Term ECG
- ClinicalTrials.gov ID
- NCT02541175
- Acronym / sponsor ID
- MC-EECG / 149/15
- Keywords
- Electrocardiography, Automation, Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Atrial Premature Complexes, Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients: Adults, hospitalised at University Hospital Bern, Dept. of Cardiology. Healthy subjects: Adults without any assumed or known cardiac disease.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Background: PubMed 23305907Haeberlin 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.
- Background: PubMed 22614730Haeberlin 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.
- Background: PubMed 24632179Haeberlin 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.
- Background: PubMed 17585079Wallmann 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.
- Derived from this study: PubMed 29993892Wildhaber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hildegard Tanner, Prof. Dr. med. principal investigator
Dept. of Cardiology, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Function, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02541175, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.