Status:
COMPLETED
Esophageal 3D Mapping System for Cardiac Arrhythmias
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Arrhythmia
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief 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 (eE...
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-stan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03365440
Start Date
December 15 2017
End Date
November 1 2019
Last Update
December 20 2019
Active Locations (1)
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1
Department of Cardiology, University Hospital Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010