A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone

NCT07842874 | Not Yet Recruiting

• 1 other identifier: FF109
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Left Bundle Branch Area Pacing; Cardiac Resynchronization Therapy; Conduction System Pacing

Outcome Measures

Primary Outcomes (1)

• 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'.

  From enrollment to 12 month follow up

Secondary Outcomes (9)

• Electrocardiographic characteristics

  enrollment to 12 month follow up

• Echocardiographic characteristics

  enrollment to 12 month follow up

• NYHA class

  enrollment to 12 month follow up

• NT-ProBNP

  enrollment to 12 month follow up

• 6 minutes walking test

  enrollment to 12 month follow up

Study Arms (2)

LOT group

OTHER

LOT group: Implanted with LOT-CRT-P device and programmed with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG.

Device: LOT-CRT-P (Programming: LOT-CRT-P)

NOT group (LBBAP)

OTHER

NOT group: Implanted with LOT-CRT-P device and programmed with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms.

Device: LOT-CRT-P (Programming: LBBAP)

Interventions

LOT-CRT-P (Programming: LBBAP) DEVICE

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.

NOT group (LBBAP)

LOT-CRT-P (Programming: LOT-CRT-P) DEVICE

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.

LOT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years Clinical indication for CRTP implantation according to the current ESC guidelines De novo implantation LBBB (QRS duration ≥130 ms) NYHA II-IV

You may not qualify if:

• Severe mitral or aortic valvular disease History of VT/VF Failed implantation of any component of the LOT-CRTP system/ incompleteness of the system to be implanted Pregnancy Life expectancy \< 1 year Inability to give written consent

Sponsors & Collaborators

• PD Dr. Guram Imnadze: lead

Study Sites (1)

University Hospital Ruppin-Brandenburg

Neuruppin, Brandenburg, 16816, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Guram PD Dr. Imnadze

CONTACT

+491733728489; g.imnadze@ukrb.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients and implanting cardiologist will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician of the Medical Clinic A- Rhythmology

Model Details: All patienties will be implanted with LOT-CRT-P.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

DE (1)