ArrhythmiaesoECG-3DNCT03365440
Esophageal 3D Mapping System for Cardiac Arrhythmias
An observational study of Arrhythmia and Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmia, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- esoECG-3D catheter
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Dec 2017to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology, University Hospital Inselspital Bern
Bern, Canton of Bern, 3010
About this study
Official title: Esophageal 3D Mapping System for Cardiac Arrhythmias: Pilot Study to Establish Basis for Improved Arrhythmia Diagnostics Using the esoECG-3D Catheter
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.
Read the detailed description
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.
- Conditions
- Arrhythmia, Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia, Supraventricular Tachycardia, Ventricular Ectopic Beat(S)
- Being tested
- esoECG-3D catheter
- Keywords
- ECG, cardiac arrhythmia, heart rhythm, esophageal ECG, non-invasive mapping, supraventricular tachycardia, atrial fibrillation, atrial flutter, extrasystole
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Tachycardia, Supraventricular, Ventricular Premature Complexes, Cardiac Complexes, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esoECG-3D catheterDevice
Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: esoECG-3D catheter | |
| EP study without transseptal passage | - 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure Receives: Device: esoECG-3D catheter | |
| Healthy participants | - 60 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording Receives: Device: esoECG-3D catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of focal trigger localization by esophageal mapping system
Reference: intracardiac recordings
Measured: within 1 year after study completion
Accuracy of cardiac activation sequence estimation by esophageal mapping system
Reference: intracardiac recordings
Measured: within 1 year after study completion
Secondary outcomes (4)
Diagnostic performance of esophageal mapping system compared to standard 12-channel ECG
Reference: intracardiac recordings
Measured: within 1 year after study completion
Accuracy of depolarization propagation speed estimation from eECGs (acquired with IMD)
Reference: intracardiac recordings
Measured: within 1 year after study completion
Accuracy of respiration estimation from eECGs (acquired with IMD)
Reference: breathing sensor recordings
Measured: 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
Measured: up to 12 hours after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start15 Dec 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hildegard Tanner, MD, Principal investigator, Department of Cardiology, University Hospital Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365440
- Sponsor's protocol ID
- CR23I2_166030
- Acronym
- esoECG-3D
- Status last verified
- Dec 2019
- First submitted
- 26 Oct 2017
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal 3D Mapping System for Cardiac Arrhythmias: Pilot Study to Establish Basis for Improved Arrhythmia Diagnostics Using the esoECG-3D Catheter
- ClinicalTrials.gov ID
- NCT03365440
- Acronym / sponsor ID
- esoECG-3D / CR23I2_166030
- Conditions
- Arrhythmia, Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia, Supraventricular Tachycardia, Ventricular Ectopic Beat(S)
- Keywords
- ECG, cardiac arrhythmia, heart rhythm, esophageal ECG, non-invasive mapping, supraventricular tachycardia, atrial fibrillation, atrial flutter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EP study with transseptal passage | – | Device: esoECG-3D catheter* 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure * Focal pacing maneuvers |
| EP study without transseptal passage | – | Device: esoECG-3D catheter- 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure |
| Healthy participants | – | Device: esoECG-3D catheter- 60 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esoECG-3D catheterRecording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor. | Device | EP study with transseptal passage, EP study without transseptal passage, Healthy participants |
Primary outcome
Accuracy of focal trigger localization by esophageal mapping system
Time frame: within 1 year after study completion
Reference: intracardiac recordings
Accuracy of cardiac activation sequence estimation by esophageal mapping system
Time frame: within 1 year after study completion
Reference: intracardiac recordings
4 secondary outcomes
Diagnostic performance of esophageal mapping system compared to standard 12-channel ECG
Time frame: within 1 year after study completion
Accuracy of depolarization propagation speed estimation from eECGs (acquired with IMD)
Time frame: within 1 year after study completion
Accuracy of respiration estimation from eECGs (acquired with IMD)
Time frame: within 1 year after study completion
Incidence of Adverse Events [Safety and Tolerability]
Time frame: up to 12 hours after study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hildegard Tanner, MD principal investigator
Department of Cardiology, University Hospital Inselspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of focal trigger localization by esophageal mapping system (time frame: within 1 year after study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.