Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy and may offer advantages over conventional biventricular pacing (BVP), including improved clinical outcomes. However, its effectiveness may be limited in patients with distal conduction system disease, significant endocardial and/or myocardial damage, as well as when direct left bundle branch capture is not achieved. Conventional CRT remains an effective therapy but is associated with procedural challenges and a significant non-responder rate. Current guidelines support the use of LBBAP and BVP either individually or in combination as Left Bundle Branch Optimized CRT (LOT-CRT). Recent data suggest that LOT-CRT may provide superior electrical and hemodynamic resynchronization compared with both LBBAP and BVP. However, there is a lack of randomized trials comparing LBBAP and LOT-CRT in patients with CRT-P indication. The aim of this study is to compare the LOT-CRTP to LBBAP alone.
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Parallel
LOT-CRT-P (Programming: LBBAP)
DeviceAll patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead. Device programming: NOT group: Synchronized with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms. After 12 months and study end, each patient receives a personalised and optimally tailored adjustment.
LOT-CRT-P (Programming: LOT-CRT-P)
DeviceDevice: LOT-CRT-P (Programming: LOT-CRT-P) All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead. Device programming: LOT group: Pacing with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG. After 12 months and study end, each patient receives a personalised and optimally tailored adjustment.
Clinical Status
Hierarchical clinical composite score: 1. Patients who died for a cardiovascular cause, received a heart transplantation or had an unplanned emergency department visit or hospitalization for heart failure are 'unchanged/worsened'. 2\. Patients who receive a modification of the implanted CRTP system for reasons of presumed inefficacy of the randomized system are 'unchanged/worsened'. 3\. Patients to whom the above does not apply and who have \>20% absolute increase in LVEF at 12 months or earlier are 'markedly improved', and patients who have \<5% absolute increase in LVEF at 12 months are 'unchanged/worsened' 4. Patients to whom the above does not apply the KCCQ-12 overall summary score will be assessed. Those who have ≥ 5 points increase in KCCQ-12 overall summary score are 'markedly improved', and patients who have ≥5 points decrease are 'unchanged/worsened'. 5\. Patients for whom none of the conditions above apply, are 'moderately improved'.
Electrocardiographic characteristics
ECG: QRS duration, assessment of LV lateral wall activation time and LV lateral wall to RV septal activation time.
Echocardiographic characteristics
left ventricular ejection fraction (LVEF), left ventricular end-systolic/ end-diastolic volume (LVESV/LVEDV), LV EDD, LV ESD.
NYHA class
NT-ProBNP
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PD Dr. Guram Imnadze
Lead sponsor
Universitatsklinikum Ruppin-Brandenburg GmbH
Sponsor institution
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