ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria

NCT ID: NCT06509763

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-29

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Cardiac Resynchronization Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Left Bundle Branch electrode implant

Group Type EXPERIMENTAL

ECGI system during LBBP implant

Intervention Type DEVICE

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

Interventions

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ECGI system during LBBP implant

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Josep Lluis Mont Girbau

Arrhythmia Section MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Maria Tolosana, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Margarida Pujol, MD, PhD

Role: STUDY_DIRECTOR

Hospital Clinic of Barcelona

Lluis Mont Girbau, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 31513945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31919928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31865972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33933414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31233818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23602768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34416669 (View on PubMed)

Other Identifiers

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GUIDE

Identifier Type: -

Identifier Source: org_study_id

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