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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04138797

Acronym

BIOSEMI-HV

Enrollment

Registered

2019-10-25

Start date

2019-10-07

Completion date

2021-01-27

Last updated

2022-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Electrophysiology, Electrocardiogram

Keywords

Signal Averaging ECG, HV interval

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.

Interventions

PROCEDUREElectrophysiological exploration

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

DEVICEECG Biosemi

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026