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

NCT04138797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-02-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Josselin DUCHATEAU, MD · University Hospital, Bordeaux

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2021-01-27
Completion
2021-01-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04138797 on ClinicalTrials.gov