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

Electrocardiogram Clinical Trial

— BIOSEMI-HV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138797
• Other study ID #: CHUBX 2019/11
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: January 27, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Electrophysiology
• Electrocardiogram

Intervention

Procedure:
• Electrophysiological 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

Device:
• ECG 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.

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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