An observational study in Arrhythmia, Atrial Fibrillation and Atrial Flutter, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-20.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
The aim of the study is to develop and validate a novel esophageal mapping system to improve the diagnostics of cardiac arrhythmias. Using a newly designed esophageal ECG catheter, esophageal ECGs (eECGs) will be recorded in 40 patients during an electrophysiological (EP) study and/or ablation procedure and in 12 healthy volunteers. In parallel acquired intracardiac electrograms will serve as reference for the developed mapping systems accuracy. Additionally, the esophageal mapping system will be compared to that of the standard 12-lead surface ECG in regard to its diagnostic performance.
Background
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
with high spatial and temporal resolution.
Secondary objectives (A2):
Safety objective (A3): Determination of safety of the esoECG-3D catheter for esophageal ECG recordings with respect to:
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.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 46 is below the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
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The study population consists of (40) adult patients that are scheduled for an elective electrophysiological study and/or ablation procedure at the study location and of (12) healthy volunteers without any known heart disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure * Focal pacing maneuvers
Device: esoECG-3D catheter
- 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure
Device: esoECG-3D catheter
- 60 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording
Device: esoECG-3D catheter
Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.
Accuracy of focal trigger localization by esophageal mapping system
Reference: intracardiac recordings
Time frame: within 1 year after study completion
Accuracy of cardiac activation sequence estimation by esophageal mapping system
Reference: intracardiac recordings
Time frame: within 1 year after study completion
Diagnostic performance of esophageal mapping system compared to standard 12-channel ECG
Reference: intracardiac recordings
Time frame: within 1 year after study completion
Accuracy of depolarization propagation speed estimation from eECGs (acquired with IMD)
Reference: intracardiac recordings
Time frame: within 1 year after study completion
Accuracy of respiration estimation from eECGs (acquired with IMD)
Reference: breathing sensor recordings
Time frame: within 1 year after study completion
Incidence of Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events to determine safety and tolerability of IMD
Time frame: up to 12 hours after study completion
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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