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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Electrophysiology, Electrocardiogram

Intervention / Treatment
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* Procedure: Electrophysiological exploration
* Device: ECG Biosemi


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrophysiological exploration & ECG Biosemi<br> | Procedure: Electrophysiological exploration<br>* Electrophysiological exploration is performed, as part of the routine care, after the Biosemi high density ECG, the same day or maximum 4 days later. It is performed in interventional rhythmology room, under fluoroscopic control. After local anesthesia, one or more introducers are placed in the femoral vein allowing the introduction of catheters. These catheters allow recording of the HV interval<br>Device: ECG Biosemi<br>* Non invasive ECG monitoring for HV measurement using high density Biosemi device. This device use 256 skin electrodes. At the same time and with the same system, a chest pressure sensor can record the patient's breathing movements.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Signal Averaging ECG, HV interval