NCT03365440|CompletedDMC
Esophageal 3D Mapping System for Cardiac Arrhythmias
esoECG-3D
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esoECG-3D
Sponsor study identifier
observational
46
1 country
1
Study Start
December 15, 2017
Actual (reported)Primary Completion
November 1, 2019
Actual (reported)Study Completion
November 1, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2017
Actual (reported)December 7, 2017
Actual (reported)December 15, 2017
Actual (reported)November 1, 2019
Actual (reported)November 1, 2019
Actual (reported)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
Diagnostic performance of esophageal mapping system compared to standard 12-channel ECG
within 1 year after study completion
* 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure * Focal pacing maneuvers
\- 15-30 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording during elective EP study and/or ablation procedure
\- 60 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording
Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Department of Cardiology, University Hospital Inselspital Bern
Bern, Canton of Bern, 3010, Switzerland
Hildegard Tanner, MD
Department of Cardiology, University Hospital Inselspital Bern
46 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2017
First Posted
December 7, 2017
Study Start
December 15, 2017
Actual (reported)Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
Accuracy of depolarization propagation speed estimation from eECGs (acquired with IMD)
within 1 year after study completion
Accuracy of respiration estimation from eECGs (acquired with IMD)
within 1 year after study completion
Incidence of Adverse Events [Safety and Tolerability]
up to 12 hours after study completion
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2019
Actual (reported)Study Completion
November 1, 2019
Actual (reported)Last Updated
December 20, 2019
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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