Clinical Trial: Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography

Brief 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. 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 Summary:

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
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: Number atrial premature beats not conducted to the ventricles [ Time Frame: during analysis of the ECG ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: September 12, 2011
Date Started: September 2011
Date Completion:
Last Updated: July 22, 2015
Last Verified: July 2015