ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria (GUIDE)

March 30, 2026 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clinic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left Bundle Branch electrode implant
Device: ECGI system during LBBP implant
ECGI system to create non-invasive ventricular maps during the screwing steps of the LBBP electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VEU
Time Frame: During procedure
Ventricular Electrical Uncoupling computed as the difference between the mean activation time of the left and the right ventricle
During procedure
LVDI
Time Frame: During procedure
Left Ventricle Dyssinchrony Index computed as the standard deviation of individual activations recorded from the left ventricle.
During procedure
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.
During procedure
LVAT
Time Frame: During procedure
Left Ventricular Activation Time computed as the difference between the earliest and the latest actvation of the left ventricle
During procedure
Isochronal Crowding
Time Frame: During procedure
Number of Isochrones presented in the left ventricular activation map to assess the homogeneity of the activation
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Jose Maria Tolosana, MD, PhD, Hospital Clinic of Barcelona
  • Study Director: Margarida Pujol, MD, PhD, Hospital Clinic of Barcelona
  • Principal Investigator: Lluis Mont Girbau, MD,PhD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

November 15, 2025

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GUIDE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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