Atrial FibrillationNCT01436344
Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography
An observational study of Atrial Fibrillation and Atrial Premature Complexes, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
With the use of esophageal Holter electrocardiography (eECG), the investigators will look for surrogate markers of paroxysmal atrial fibrillation. To do so, the investigators will record eECGs in patients with known paroxysmal atrial fibrillation but at the time of eECG-recording in sinus rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Premature Complexes
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2011to Apr 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients hospitalized on the cardiology ward (for any reasons). Additionally, also patients referred to the cardiology ambulatorium for a long-term ECG will be asked to participate the study.
Who may be able to join
- Age >/= 18 years
- Written informed consent
- Hospitalized patient on the cardiology ward or referred to the cardiological ambulatory
- Paroxysmal atrial fibrillation but in sinus rhythm at the time of inclusion (cases)
- Sinus rhythm without known heart rhythm disorders (controls)
Who cannot join
- Persistent atrial fibrillation
- Pacemaker/ICD with atrial electrode
- History of ablation of atrial fibrillation
- Instable angina pectoris/acute myocardial infarction before revascularisation
- Cardiorespiratory unstable patients
- History of heart transplantation
Show all 11Show fewer
- Known severe bleeding diathesis
- Carcinoma of the esophagus or nasopharynx
- Pregnancy
- History of valve replacement operation less than 4 weeks ago
- Obstructive cardiomyopathy with severe dynamic LVOT-obstruction
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology, Bern University Hospital
Bern, Canton of Bern, 3010 Bern
About this study
With the use of esophageal Holter electrocardiography (eECG), the investigators will look for surrogate markers of paroxysmal atrial fibrillation. To do so, the investigators will record eECGs in patients with known paroxysmal atrial fibrillation but at the time of eECG-recording in sinus rhythm. To identify markers, the eECGs of those patients will be compared to a group of controls in sinus rhythm without atrial fibrillation. The investigators hypothesis is that it is possible to identify surrogate markers in patients with paroxysmal atrial fibrillation.
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 has 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 uf 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 we 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.
The diagnosis of paroxysmal atrial fibrillation (pAF) can only be made if an episode of atrial fibrillation occurs during the long-term ECG recording. Surrogate markers of pAF could identify a "population at risk" in which pAF has to be suspected although they show sinus rhythm during the time of recording. In surface ECG such markers have been suspected. The use of esophageal long-term electrocardiography with its better signal properties is a promising alternative to find such surrogate markers for risk stratification.
Objective
Identification and characterization of surrogate markers indicative for pAF in patients with sinus rhythm at the time of recording.
Methods
A total of 60 patients will be included to identify and characterize surrogate markers for pAF. Cases with known pAF will consecutively be recruited from the cardiology ward and the cardiological ambulatory. After inclusion, an age (+/- one year) and gender adjusted control person without known pAF (negative 7-day ECG within the previous 365 days before study inclusion) will be matched to every patient. Cases and controls will receive a simultaneous 24-hour esophageal electrocardiography and standard surface electrocardiography. Controls without negative 7-day ECG within the past year will have to wear the surface ECG recorder for additional 6 days (total surface ECG recording of 7 days). In the case that paroxysmal atrial fibrillation is detected for the very first time during the study, patients will be allocated to the "case" group.
Additionally, in all patients LA diameter parasternal will be measured echocardiographically.
- Conditions
- Atrial Fibrillation, Atrial Premature Complexes
- Keywords
- esophageal electrocardiography, electrocardiography, atrial electrogram, atrial function, left
- Medical subject headings
- Atrial Fibrillation, Atrial Premature Complexes
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 |
|---|---|---|
| 1 | Cases: 30 patients with known paroxysmal atrial fibrillation (pAF) will consecutively be recruited from the cardiology ward and the cardiological ambulatory. They will form the "cases" group. | |
| 2 | Controls: For every case patient, an age (+/- one year) and gender matched control person (n=30) without known paroxysmal atrial fibrillation will be included and matched to every case patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number atrial premature beats not conducted to the ventricles
Measured: during analysis of the ECG
Secondary outcomes (5)
Mean duration of the p-eso-wave
Measured: during analysis of the esophageal ECG
Mean duration of the left atrial wavefront
Measured: during analysis of the esophageal ECG
p-eso-wave-duration-dispersion
Measured: during analysis of the esophageal ECG
mean number of p-eso-wave-peaks
Measured: during analysis of the esophageal ECG
root mean square voltages of the last 20 ms of the p-eso-wave in the esophageal ECG
Measured: during analysis of the esophageal ECG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Commission for Technology and Innovation
- Investigators
- Rolf Vogel, MD, PhD, Principal investigator, Bern University HospitalAndreas D Haeberlin, MD, Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436344
- Sponsor's protocol ID
- 084/11
- Status last verified
- Jul 2015
- First submitted
- 12 Sep 2011
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22614730
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography
- ClinicalTrials.gov ID
- NCT01436344
- Acronym / sponsor ID
- 084/11
- Conditions
- Atrial Fibrillation, Atrial Premature Complexes
- Keywords
- esophageal electrocardiography, electrocardiography, atrial electrogram, atrial function, left
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss Commission for Technology and Innovation
- Study start
- Sep 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Sep 2011 (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.
With the use of esophageal Holter electrocardiography (eECG), the investigators will look for surrogate markers of paroxysmal atrial fibrillation. To do so, the investigators will record eECGs in patients with known paroxysmal atrial fibrillation but at the time of eECG-recording in sinus rhythm. To identify markers, the eECGs of those patients will be compared to a group of controls in sinus rhythm without atrial fibrillation. The investigators hypothesis is that it is possible to identify surrogate markers in patients with paroxysmal atrial fibrillation.
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 has 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 uf 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 we 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.
The diagnosis of paroxysmal atrial fibrillation (pAF) can only be made if an episode of atrial fibrillation occurs during the long-term ECG recording. Surrogate markers of pAF could identify a "population at risk" in which pAF has to be suspected although they show sinus rhythm during the time of recording. In surface ECG such markers have been suspected. The use of esophageal long-term electrocardiography with its better signal properties is a promising alternative to find such surrogate markers for risk stratification.
Objective
Identification and characterization of surrogate markers indicative for pAF in patients with sinus rhythm at the time of recording.
Methods
A total of 60 patients will be included to identify and characterize surrogate markers for pAF. Cases with known pAF will consecutively be recruited from the cardiology ward and the cardiological ambulatory. After inclusion, an age (+/- one year) and gender adjusted control person without known pAF (negative 7-day ECG within the previous 365 days before study inclusion) will be matched to every patient. Cases and controls will receive a simultaneous 24-hour esophageal electrocardiography and standard surface electrocardiography. Controls without negative 7-day ECG within the past year will have to wear the surface ECG recorder for additional 6 days (total surface ECG recording of 7 days). In the case that paroxysmal atrial fibrillation is detected for the very first time during the study, patients will be allocated to the "case" group.
Additionally, in all patients LA diameter parasternal will be measured echocardiographically.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Cases: 30 patients with known paroxysmal atrial fibrillation (pAF) will consecutively be recruited from the cardiology ward and the cardiological ambulatory. They will form the "cases" group. |
| 2 | – | –Controls: For every case patient, an age (+/- one year) and gender matched control person (n=30) without known paroxysmal atrial fibrillation will be included and matched to every case patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients hospitalized on the cardiology ward (for any reasons). Additionally, also patients referred to the cardiology ambulatorium for a long-term ECG will be asked to participate the study.
Key inclusion criteria (5 listed)
- Age >/= 18 years
- Written informed consent
- Hospitalized patient on the cardiology ward or referred to the cardiological ambulatory
- Paroxysmal atrial fibrillation but in sinus rhythm at the time of inclusion (cases)
- Sinus rhythm without known heart rhythm disorders (controls)
Key exclusion criteria (11 listed)
- Persistent atrial fibrillation
- Pacemaker/ICD with atrial electrode
- History of ablation of atrial fibrillation
- Instable angina pectoris/acute myocardial infarction before revascularisation
- Cardiorespiratory unstable patients
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 atrial premature beats not conducted to the ventricles
Time frame: during analysis of the ECG
5 secondary outcomes
Mean duration of the p-eso-wave
Time frame: during analysis of the esophageal ECG
Mean duration of the left atrial wavefront
Time frame: during analysis of the esophageal ECG
p-eso-wave-duration-dispersion
Time frame: during analysis of the esophageal ECG
mean number of p-eso-wave-peaks
Time frame: during analysis of the esophageal ECG
root mean square voltages of the last 20 ms of the p-eso-wave in the esophageal ECG
Time frame: during analysis of the esophageal ECG
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 23 Jul 2015.
- Derived from this study: 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.
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Atrial Fibrillation (AF)
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.
Rolf Vogel, MD, PhD principal investigator
Bern University Hospital
Andreas D Haeberlin, MD principal investigator
Bern University Hospital
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 Premature Complexes, 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 5 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 23 Jul 2015. 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 atrial premature beats not conducted to the ventricles (time frame: during analysis of the ECG). 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 NCT01436344, which also lists 1 linked publication.
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 23 Jul 2015.