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Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Hospital Inselspital, Berne
Sponsor:
Collaborator:
Commission for Technology and Innovation of the Swiss Federal Administration
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01436344
First received: September 12, 2011
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition
Atrial Fibrillation
Atrial Premature Complexes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Number atrial premature beats not conducted to the ventricles [ Time Frame: during analysis of the ECG ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean duration of the p-eso-wave [ Time Frame: during analysis of the esophageal ECG ] [ Designated as safety issue: No ]
  • Mean duration of the left atrial wavefront [ Time Frame: during analysis of the esophageal ECG ] [ Designated as safety issue: No ]
  • p-eso-wave-duration-dispersion [ Time Frame: during analysis of the esophageal ECG ] [ Designated as safety issue: No ]
  • mean number of p-eso-wave-peaks [ Time Frame: during analysis of the esophageal ECG ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436344

Contacts
Contact: Andreas D Haeberlin, MD +41 31 632 75 87 Andreas.Haeberlin@insel.ch
Contact: Rolf Vogel, MD, PhD Rolf.vogel.@spital.so.ch

Locations
Switzerland
Department of Cardiology, Bern University Hospital Recruiting
Bern, Switzerland, 3010 Bern
Contact: Andreas D Haeberlin, MD    +41 31 632 75 87    andreas.haeberlin@insel.ch   
Principal Investigator: Rolf Vogel, MD, PhD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Commission for Technology and Innovation of the Swiss Federal Administration
Investigators
Principal Investigator: Rolf Vogel, MD, PhD Bern University Hospital
Principal Investigator: Andreas D Haeberlin, MD Bern University Hospital
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rolf Vogel, MD, MD-PhD, University Hospital Bern, Dept. of Cardiology
ClinicalTrials.gov Identifier: NCT01436344     History of Changes
Other Study ID Numbers: 084/11
Study First Received: September 12, 2011
Last Updated: December 20, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
esophageal electrocardiography
electrocardiography
atrial electrogram
atrial function, left

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Premature Complexes
Arrhythmias, Cardiac
Cardiac Complexes, Premature
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014