ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria

Not Applicable

Active, not recruiting

• Conditions: Cardiac Resynchronization Therapy
• Interventions: Device: ECGI system during LBBP implant

• Registration Number: NCT06509763
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-29
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Primary Completion: 2024-10-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Left Bundle Branch electrode implant	ECGI system during LBBP implant	-

Primary Outcome Measures

Name	Time	Method
Left ventricular resynchronization assessed by ECGI	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 Outcome Measures

Name	Time	Method
LVDI	During procedure	Left Ventricle Dyssinchrony Index computed as the standard deviation of individual activations recorded from the left ventricle.
VEU	During procedure	Ventricular Electrical Uncoupling computed as the difference between the mean activation time of the left and the right ventricle
LVAT	During procedure	Left Ventricular Activation Time computed as the difference between the earliest and the latest actvation of the left ventricle
Isochronal Crowding	During procedure	Number of Isochrones presented in the left ventricular activation map to assess the homogeneity of the activation
Histogram Overlap	During procedure	Overlapping of the right ventricle and left ventricle activation times histogram distributions as a parameter to assess the dyssinchrony between ventricles.

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain