ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria

Hospital Clinic of Barcelona50 enrolled

Overview

The goal is to validate the resynchronization criteria with a non-invasive technique, during the LBBP implant. Non-invasive real-time ventricular activation maps will be created and analyzed before, during, and after the implantation of the left bundle branch lead, including right septal pacing, mid and deep septal pacing and pacing when reaching the left bundle branch according to the published standard LBBP criteria. Using these maps, the investigators will quantify activation times and evaluate changes in the ventricular sequence during implantation.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cardiac Resynchronization Therapy

Interventions

ECGI system during LBBP implantDEVICE

ECGI system to create non-invasive ventricular maps during the screwing steps of the LBBP electrode

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Left bundle branch pacing indication * Capability of standing up to place the ECGI vest Exclusion Criteria: * Less than 18 years-old * Patients with cognitive impairment

Locations (1)

Hospital Clinic de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

Left ventricular resynchronization assessed by ECGI

Resynchronization assesed by non-invasive ECGI by the Left Ventricle Activation Time reduction and the septal activation ventricular pattern once reaching the LBBP according to the published ECG criteria.

Time frame: During procedure

Secondary Outcomes

VEU

Ventricular Electrical Uncoupling computed as the difference between the mean activation time of the left and the right ventricle

Time frame: During procedure

LVDI

Left Ventricle Dyssinchrony Index computed as the standard deviation of individual activations recorded from the left ventricle.

Time frame: During procedure

Histogram Overlap

Overlapping of the right ventricle and left ventricle activation times histogram distributions as a parameter to assess the dyssinchrony between ventricles.

Time frame: During procedure

LVAT

Left Ventricular Activation Time computed as the difference between the earliest and the latest actvation of the left ventricle

Time frame: During procedure

Isochronal Crowding

Number of Isochrones presented in the left ventricular activation map to assess the homogeneity of the activation

Time frame: During procedure

Data from ClinicalTrials.gov

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