Esophageal 3D Mapping System for Cardiac Arrhythmias

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Esophageal 3D Mapping System for Cardiac Arrhythmias: Pilot Study to Establish Basis for Improved Arrhythmia Diagnostics Using the esoECG-3D Catheter

Conditions
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Arrhythmia, Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia, Supraventricular Tachycardia, Ventricular Ectopic Beat(S), Cardiac Arrythmias

Intervention / Treatment
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* Device: esoECG-3D catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent as documented by signature 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: Contraindications to the class of devices under study, e.g. known hypersensitivity or allergy to class of devices or the investigational device 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EP study with transseptal passage<br>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<br>* Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.<br>|
| EP study without transseptal passage<br>- 15-30 minute esophageal ECG (using esoECG-3D catheter) & respiration recording during elective EP study and/or ablation procedure | Device: esoECG-3D catheter<br>* Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.<br>|
| Healthy participants<br>- 60 minute esophageal ECG (using esoECG-3D catheter) & respiration recording | Device: esoECG-3D catheter<br>* Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of focal trigger localization by esophageal mapping system | Reference: intracardiac recordings | within 1 year after study completion | 
| Accuracy of cardiac activation sequence estimation by esophageal mapping system | Reference: intracardiac recordings | within 1 year after study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of esophageal mapping system compared to standard 12-channel ECG | Reference: intracardiac recordings | within 1 year after study completion | 
| Accuracy of depolarization propagation speed estimation from eECGs (acquired with IMD) | Reference: intracardiac recordings | within 1 year after study completion | 
| Accuracy of respiration estimation from eECGs (acquired with IMD) | Reference: breathing sensor recordings | 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 | up to 12 hours after study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, cardiac arrhythmia, heart rhythm, esophageal ECG, non-invasive mapping, supraventricular tachycardia, atrial fibrillation, atrial flutter, extrasystole