A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone (LOT or NOT)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Guram PD Dr. Imnadze
- Número de teléfono: +491733728489
- Correo electrónico: g.imnadze@ukrb.de
Ubicaciones de estudio
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Brandenburg
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Neuruppin, Brandenburg, Alemania, 16816
- University Hospital Ruppin-Brandenburg
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Contacto:
- Guram Imnadze, MD, PhD
- Número de teléfono: +493391393111
- Correo electrónico: imnadze@web.de
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: LOT group
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) 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. |
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Otro: NOT group (LBBAP)
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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical Status
Periodo de tiempo: From enrollment to 12 month follow up
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Electrocardiographic characteristics
Periodo de tiempo: enrollment to 12 month follow up
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ECG: QRS duration, assessment of LV lateral wall activation time and LV lateral wall to RV septal activation time. |
enrollment to 12 month follow up
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Echocardiographic characteristics
Periodo de tiempo: enrollment to 12 month follow up
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left ventricular ejection fraction (LVEF), left ventricular end-systolic/ end-diastolic volume (LVESV/LVEDV), LV EDD, LV ESD. |
enrollment to 12 month follow up
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NYHA class
Periodo de tiempo: enrollment to 12 month follow up
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enrollment to 12 month follow up
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NT-ProBNP
Periodo de tiempo: enrollment to 12 month follow up
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enrollment to 12 month follow up
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6 minutes walking test
Periodo de tiempo: enrollment to 12 month follow up
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enrollment to 12 month follow up
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Quality of Life Questionaire
Periodo de tiempo: enrollment to 12 month follow up
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KCCQ-12 |
enrollment to 12 month follow up
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Worsened heart failure
Periodo de tiempo: enrollment to 12 month follow up
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enrollment to 12 month follow up
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Arrhythmic events
Periodo de tiempo: enrollment to 12 month follow up
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VT/VF/AF occurrence |
enrollment to 12 month follow up
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Mortality
Periodo de tiempo: enrollment to 12 month follow up
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enrollment to 12 month follow up
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FF109
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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