Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2017-12-15
2019-11-01
Brief Summary
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Detailed Description
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Cardiac arrhythmias are common and may have devastating consequences for affected patients. To prevent f.e. strokes due to atrial fibrillation, heart failures as a consequence of long-standing tachyarrhythmias or death due to ventricular fibrillation, accurate and timely diagnoses are essential. The standard diagnostic tool for heart rhythm disorders in everyday clinical life is the 12-channel surface electrocardiogram (ECG). However, despite its strengths, the surface ECG suffers from several limitations. Especially on the supraventricular level, the low atrial signal amplitude renders it prone to errors and causes surface ECGs to quickly reach the limits of their diagnostic capacities.
This limitation could be overcome by recordings through the esophagus. Owing the close anatomical relationship, esophageal ECGs have an excellent atrial signal quality. To fully exploit their potential, a novel esophageal ECG catheter (esoECG catheter) with 3-dimensional electrode arrangement was developed. The aim of this study is to use the esoECG-3D catheter to develop and validate a non-invasive esophageal mapping system in order to improve the diagnostics of cardiac arrhythmias and consequently the therapy of patients suffering from these disorders.
Objectives
Primary objective (A1): Development of an esophageal non-invasive mapping system which shall be able to depict
* A1.1: the source of focal triggers
* A1.2: the sequence of cardiac depolarization
with high spatial and temporal resolution.
Secondary objectives (A2):
* A2.1: outperform the diagnostic accuracy of 12-lead ECGs in bedside arrhythmia diagnostics
* A2.2: estimate the speed of myocardial depolarization on the left atrial wall from esophageal ECG tracings
* A2.3: extract respiration signals from esophageal ECG tracings
* A2.4: determine the wearing comfort of the device
* A2.5: determine the operability of the device
Safety objective (A3): Determination of safety of the esoECG-3D catheter for esophageal ECG recordings with respect to:
* A3.1: device related adverse events
* A3.2: device related serious adverse events
* A3.3: device failures, including insertion failure
Methods
Esophageal ECGs will be acquired from a total of 52 participants using the esophageal esoECG-3D catheter. 40 of these will be recorded during an electrophysiological study and/or ablation procedure to obtain a reference (intracardiac measurements) for the evaluation of outcome measures. In a subset of patients, defined pacing maneuvers will be performed; 12-channel ECG and breathing sensor recordings will be obtained from all participants in parallel to eECG measurements. The acquired data will be used for development of algorithms to non-invasively map the hearts depolarization process from recordings in the esophagus. Outcome evaluation will be performed after completion of all measurements and after implementation of the final mapping algorithms.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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EP study with transseptal passage
* 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure
* Focal pacing maneuvers
esoECG-3D catheter
Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.
EP study without transseptal passage
\- 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure
esoECG-3D catheter
Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.
Healthy participants
\- 60 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording
esoECG-3D catheter
Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.
Interventions
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esoECG-3D catheter
Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
* Group 1: Patients scheduled for an elective electrophysiological study and/or ablation procedure including a transseptal passage
* Group 2: Patients, scheduled for an elective electrophysiological study and/or ablation procedure without transseptal passage
* Group 3: Healthy volunteers, without any known cardiac disease
Exclusion Criteria
* Status post atrial fibrillation ablation within the last 4 weeks
* Unstable angina pectoris or acute coronary syndrome
* Hemodynamic instability
* Respiratory instability
* Disease or malformation of the upper airways or esophagus, making naso-esophageal catheter insertion impossible
* Hereditary severe bleeding diathesis
* Status post surgical intervention of the esophagus or stomach within the last 4 weeks
* Known cancer of the esophagus or stomach
* Pregnancy
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
18 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Hildegard Tanner, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, University Hospital Inselspital Bern
Locations
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Department of Cardiology, University Hospital Inselspital Bern
Bern, Canton of Bern, Switzerland
Countries
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Other Identifiers
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CR23I2_166030
Identifier Type: -
Identifier Source: org_study_id