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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left Bundle Branch electrode implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECGI system during LBBP implant | Device | ECGI system to create non-invasive ventricular maps during the screwing steps of the LBBP electrode |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VEU | Ventricular Electrical Uncoupling computed as the difference between the mean activation time of the left and the right ventricle | During procedure |
| LVDI | Left Ventricle Dyssinchrony Index computed as the standard deviation of individual activations recorded from the left ventricle. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31513945 | Background | 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. | |
| 31919928 | Background |
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| During procedure |
| Histogram Overlap | Overlapping of the right ventricle and left ventricle activation times histogram distributions as a parameter to assess the dyssinchrony between ventricles. | During procedure |
| LVAT | Left Ventricular Activation Time computed as the difference between the earliest and the latest actvation of the left ventricle | During procedure |
| Isochronal Crowding | Number of Isochrones presented in the left ventricular activation map to assess the homogeneity of the activation | During procedure |
| 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. |
| 31865972 | 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. |
| 33933414 | 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. |
| 31233818 | 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. |
| 23602768 | 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. |
| 34416669 | 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. |