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A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone
Sponsor: PD Dr. Guram Imnadze
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2027-02
Completion Date
2029-03
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
LOT-CRT-P (Programming: LBBAP)
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: 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)
Device: 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.
Locations (1)
University Hospital Ruppin-Brandenburg
Neuruppin, Brandenburg, Germany