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

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.

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Key information

Conditions

Cardiac Electrophysiology Electrocardiogram

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital

Pessac, 33604, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electrophysiological exploration

Procedure

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

ECG Biosemi

Device

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.

Primary outcomes

Measurement of HV interval correlation by the intra-class correlation coefficient

Time frame: Day 0

The correlation of the HV interval obtained using the 2 different methods, is measured by a correlation coefficient
Measurement of HV interval correlation by graphical representation

Time frame: Day 0

The correlation of the HV interval obtained using the 2 different methods, is measured by a graphical representation of Bland and Altman

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: BIOSEMI-HV

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Oct 25, 2019
Registry last updated: Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed