Esophageal 3D Mapping System for Cardiac Arrhythmias

NCT03365440 | Completed DMC

• 1 other identifier: CR23I2_166030
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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 (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

Arrhythmia; Atrial Fibrillation; Atrial Flutter; Atrial Tachycardia; Supraventricular Tachycardia; Ventricular Ectopic Beat(S); Cardiac Arrythmias

Keywords

ECG; cardiac arrhythmia; heart rhythm; esophageal ECG; non-invasive mapping; supraventricular tachycardia; atrial fibrillation; atrial flutter; extrasystole

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Diagnostic performance of esophageal mapping system compared to standard 12-channel ECG

  within 1 year after study completion

• 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

Study Arms (3)

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

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

Device: esoECG-3D catheter

Healthy participants

\- 60 minute esophageal ECG (using esoECG-3D catheter) \& respiration recording

Device: esoECG-3D catheter

Interventions

esoECG-3D catheter DEVICE

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

EP study with transseptal passage; EP study without transseptal passage; Healthy participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Cardiology, University Hospital Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Tachycardia, Supraventricular; Ventricular Premature Complexes; Cardiac Complexes, Premature

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Hildegard Tanner, MD

  Department of Cardiology, University Hospital Inselspital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: December 7, 2017
• Study Start: December 15, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

CH (1)