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Esophageal 3D Mapping System for Cardiac Arrhythmias

NCT03365440 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2019-12-20

No results posted yet for this study

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 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.

Conditions

Interventions

DEVICE

esoECG-3D catheter

Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Hildegard Tanner, MD · Department of Cardiology, University Hospital Inselspital Bern

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03365440 on ClinicalTrials.gov