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

University Hospital of Bordeaux

Status: Completed

Conditions: Electrocardiogram; Cardiac Electrophysiology

Treatments: Procedure: Electrophysiological exploration; Device: ECG Biosemi

Study type: Interventional

Funder types: Other

Identifiers

NCT04138797

CHUBX 2019/11

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Electrophysiological exploration & ECG Biosemi

Experimental group

Treatment:

Device: ECG Biosemi

Procedure: Electrophysiological exploration