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

NCT04138797 | Completed

• 1 other identifier: CHUBX 2019/11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Electrophysiology; Electrocardiogram

Keywords

Signal Averaging ECG; HV interval

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Electrophysiological exploration & ECG Biosemi

EXPERIMENTAL

Procedure: Electrophysiological exploration; Device: ECG Biosemi

Interventions

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

Electrophysiological exploration & ECG Biosemi

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.

Electrophysiological exploration & ECG Biosemi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

Study Officials

• Josselin DUCHATEAU, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: October 7, 2019
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

FR (1)