Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device

Not Applicable

Completed

• Conditions: Cardiac Electrophysiology; Electrocardiogram
• Interventions: Procedure: Electrophysiological exploration; Device: ECG Biosemi

• Registration Number: NCT04138797
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

His-Ventricle (HV) measurement is only obtained invasively using transvenous catheters. This kind of procedure is routinely performed but some risks of complication exist. HV interval prolongation is correlated with increased risk of occurrence of complete atrioventricular block which could lead to syncope or cardiac sudden death. A new non invasive, high density and high fidelity system (BioSemi, BioSemi B.V., Amsterdam, Netherlands) can theorically collect such electrophysiological signal using a signal averaging acquisition method. We want to assess the possibility of non invasive HV interval measurement using this new device.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-07
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Primary Completion: 2021-01-27
• Study Completion: 2021-01-27
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients admitted at Bordeaux University Hospital for electrophysiological study with HV measurement.

Exclusion Criteria

• Patients under 18 years old,
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrophysiological exploration & ECG Biosemi	ECG Biosemi	-
Electrophysiological exploration & ECG Biosemi	Electrophysiological exploration	-

Primary Outcome Measures

Name	Time	Method
Measurement of HV interval correlation by graphical representation	Day 0	The correlation of the HV interval obtained using the 2 different methods, is measured by a graphical representation of Bland and Altman
Measurement of HV interval correlation by the intra-class correlation coefficient	Day 0	The correlation of the HV interval obtained using the 2 different methods, is measured by a correlation coefficient

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Pessac, France