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Completed

NCT Number: NCT06509763

ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria

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.

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Key information

Conditions

Cardiac Resynchronization Therapy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECGI system during LBBP implant

Device

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

Primary outcomes

  1. Left ventricular resynchronization assessed by ECGI

    Time frame: During procedure

    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.

Secondary outcomes

  1. VEU

    Time frame: During procedure

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

  2. LVDI

    Time frame: During procedure

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

  3. Histogram Overlap

    Time frame: During procedure

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

  4. LVAT

    Time frame: During procedure

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

  5. Isochronal Crowding

    Time frame: During procedure

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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Acronym: GUIDE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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