Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07842874

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ruppin-Brandenburg

Neuruppin, Brandenburg, 16816, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Clinical Status

    Time frame: From enrollment to 12 month follow up

    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'.

    • Patients who receive a modification of the implanted CRTP system for reasons of presumed inefficacy of the randomized system are 'unchanged/worsened'.
    • 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'.
    • Patients for whom none of the conditions above apply, are 'moderately improved'.

Secondary outcomes

  1. Electrocardiographic characteristics

    Time frame: enrollment to 12 month follow up

    ECG: QRS duration, assessment of LV lateral wall activation time and LV lateral wall to RV septal activation time.

  2. Echocardiographic characteristics

    Time frame: enrollment to 12 month follow up

    left ventricular ejection fraction (LVEF), left ventricular end-systolic/ end-diastolic volume (LVESV/LVEDV), LV EDD, LV ESD.

  3. NYHA class

    Time frame: enrollment to 12 month follow up

  4. NT-ProBNP

    Time frame: enrollment to 12 month follow up

  5. 6 minutes walking test

    Time frame: enrollment to 12 month follow up

  6. Quality of Life Questionaire

    Time frame: enrollment to 12 month follow up

    KCCQ-12

  7. Worsened heart failure

    Time frame: enrollment to 12 month follow up

  8. Arrhythmic events

    Time frame: enrollment to 12 month follow up

    VT/VF/AF occurrence

  9. Mortality

    Time frame: enrollment to 12 month follow up

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

PD Dr. Guram Imnadze

Other

Registry information

Acronym: LOT or NOT

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.