Ignite Creation Date:
2025-12-18 @ 9:22 AM
Ignite Modification Date:
2025-12-23 @ 10:30 PM
Study NCT ID:
NCT03365440
Status:
None
Last Update Posted:
2019-12-20 00:00:00
First Post:
2017-10-26 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Esophageal 3D Mapping System for Cardiac Arrhythmias
Sponsor:
None
Organization:
Study Overview
Official Title:
Esophageal 3D Mapping System for Cardiac Arrhythmias: Pilot Study to Establish Basis for Improved Arrhythmia Diagnostics Using the esoECG-3D Catheter
Status:
None
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
esoECG-3D
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: