ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria

NCT06509763 | Active Not Recruiting

• 1 other identifier: GUIDE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronization Therapy

Keywords

Electrocardiographic Imaging; Left Bundle Branch Pacing; Cardiac Resynchronization Therapy; Conduction System Pacing

Outcome Measures

Primary Outcomes (1)

• 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.

  During procedure

Secondary Outcomes (5)

• VEU

  During procedure

• LVDI

  During procedure

• Histogram Overlap

  During procedure

• LVAT

  During procedure

• Isochronal Crowding

  During procedure

Study Arms (1)

Left Bundle Branch electrode implant

EXPERIMENTAL

Device: ECGI system during LBBP implant

Interventions

ECGI system during LBBP implant DEVICE

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

Left Bundle Branch electrode implant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left bundle branch pacing indication
• Capability of standing up to place the ECGI vest

You may not qualify if:

• Less than 18 years-old
• Patients with cognitive impairment

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Location

Related Publications (7)

• Zhang W, Huang J, Qi Y, Wang F, Guo L, Shi X, Wu W, Zhou X, Li R. Cardiac resynchronization therapy by left bundle branch area pacing in patients with heart failure and left bundle branch block. Heart Rhythm. 2019 Dec;16(12):1783-1790. doi: 10.1016/j.hrthm.2019.09.006. Epub 2019 Sep 9.

  PMID: 31513945 BACKGROUND

• Cai B, Huang X, Li L, Guo J, Chen S, Meng F, Wang H, Lin B, Su M. Evaluation of cardiac synchrony in left bundle branch pacing: Insights from echocardiographic research. J Cardiovasc Electrophysiol. 2020 Feb;31(2):560-569. doi: 10.1111/jce.14342. Epub 2020 Jan 20.

  PMID: 31919928 BACKGROUND

• Zhang S, Zhou X, Gold MR. Left Bundle Branch Pacing: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Dec 17;74(24):3039-3049. doi: 10.1016/j.jacc.2019.10.039. Epub 2019 Dec 9.

  PMID: 31865972 BACKGROUND

• Wu S, Chen X, Wang S, Xu L, Xiao F, Huang Z, Zheng R, Jiang L, Vijayaraman P, Sharma PS, Su L, Huang W. Evaluation of the Criteria to Distinguish Left Bundle Branch Pacing From Left Ventricular Septal Pacing. JACC Clin Electrophysiol. 2021 Sep;7(9):1166-1177. doi: 10.1016/j.jacep.2021.02.018. Epub 2021 Apr 28.

  PMID: 33933414 BACKGROUND

• Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.

  PMID: 31233818 BACKGROUND

• Ploux S, Lumens J, Whinnett Z, Montaudon M, Strom M, Ramanathan C, Derval N, Zemmoura A, Denis A, De Guillebon M, Shah A, Hocini M, Jais P, Ritter P, Haissaguerre M, Wilkoff BL, Bordachar P. Noninvasive electrocardiographic mapping to improve patient selection for cardiac resynchronization therapy: beyond QRS duration and left bundle branch block morphology. J Am Coll Cardiol. 2013 Jun 18;61(24):2435-2443. doi: 10.1016/j.jacc.2013.01.093. Epub 2013 Apr 16.

  PMID: 23602768 BACKGROUND

• Elliott MK, Blauer J, Mehta VS, Sidhu BS, Gould J, Jackson T, Sieniewicz B, Niederer S, Ghosh S, Rinaldi CA. Comparison of electrical dyssynchrony parameters between electrocardiographic imaging and a simulated ECG belt. J Electrocardiol. 2021 Sep-Oct;68:117-123. doi: 10.1016/j.jelectrocard.2021.08.003. Epub 2021 Aug 8.

  PMID: 34416669 BACKGROUND

Study Officials

• Jose Maria Tolosana, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Margarida Pujol, MD, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

• Lluis Mont Girbau, MD,PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arrhythmia Section MD PhD

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: September 29, 2022
• Primary Completion: October 15, 2024
• Study Completion: November 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)