Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography

NCT01436344 | Completed

• 1 other identifier: 084/11
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Premature Complexes

Keywords

esophageal electrocardiography; electrocardiography; atrial electrogram; atrial function, left

Outcome Measures

Primary Outcomes (1)

• Number atrial premature beats not conducted to the ventricles

  during analysis of the ECG

Secondary Outcomes (5)

• Mean duration of the p-eso-wave

  during analysis of the esophageal ECG

• Mean duration of the left atrial wavefront

  during analysis of the esophageal ECG

• p-eso-wave-duration-dispersion

  during analysis of the esophageal ECG

• mean number of p-eso-wave-peaks

  during analysis of the esophageal ECG

• root mean square voltages of the last 20 ms of the p-eso-wave in the esophageal ECG

  during analysis of the esophageal ECG

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Age \>/= 18 years
• Written informed consent
• Hospitalized patient on the cardiology ward or referred to the cardiological ambulatory
• Sinus rhythm without known heart rhythm disorders (controls)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss Commission for Technology and Innovation: collaborator

Study Sites (1)

Department of Cardiology, Bern University Hospital

Bern, Canton of Bern, 3010 Bern, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22614730 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease

Study Officials

• Rolf Vogel, MD, PhD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Andreas D Haeberlin, MD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 19, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

CH (1)