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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Switzerland

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.

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 groups in NCT01436344
Study groupRoleWhat they receive
1Cases: 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.
2Controls: 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.

  1. Number atrial premature beats not conducted to the ventricles

    Measured: during analysis of the ECG

Secondary outcomes (5)
  1. Mean duration of the p-eso-wave

    Measured: during analysis of the esophageal ECG

  2. Mean duration of the left atrial wavefront

    Measured: during analysis of the esophageal ECG

  3. p-eso-wave-duration-dispersion

    Measured: during analysis of the esophageal ECG

  4. mean number of p-eso-wave-peaks

    Measured: during analysis of the esophageal ECG

  5. 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.

  1. First posted19 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2015
  4. Study completionApr 2015

Resources

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)
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

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.

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