Clinical trial NCT06509763: ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria
Official title: ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Resynchronization Therapy
Keywords: Electrocardiographic Imaging
Left Bundle Branch Pacing
Cardiac Resynchronization Therapy
Conduction System Pacing
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular resynchronization assessed by ECGI
timeFrame: During procedure
Secondary outcomes:
measure: VEU
timeFrame: During procedure
measure: LVDI
timeFrame: During procedure
measure: Histogram Overlap
timeFrame: During procedure
measure: LVAT
timeFrame: During procedure
measure: Isochronal Crowding
timeFrame: During procedure
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jose Maria Tolosana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Margarida Pujol, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clinic of Barcelona
name: Lluis Mont Girbau, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.