Impact of Intraventricular Electrical Activation in Resynchronization Therapy (CARTO-CRT)
Study of the Role of Intraventricular Electrical Activation in the Treatment of Congestive Heart Failure by Cardiac Resynchronization Therapy: Invasive Evaluation and Validation of Non-Invasive Strategy Using CardioInsight ®
Descripción general del estudio
Estado
Descripción detallada
Comprehensive study, prospective, monocentric and cohort study.
Biventricular pacing is an effective therapy to improve end stage heart failure patients, however up to 30% of patients are unresponsive to this therapy. Among others, optimization of Left Ventricle (LV) pacing site location is critical to optimize response to Cardiac Resynchronization Therapy (CRT). Whether a better comprehension of baseline LV electrical activation can help to determine optimal LV lead location remains to be investigated.
After informed consent patients are included in the sudy. Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the LV cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Quantitative parameters: Global LV activation time (LVATG) (primary outcome); septal activation time (LVTAS); Global intra-LV dispersion time and Qualitative parameters: presence of intraLV line of block, area of late activation. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. A 3 and 6 months follow-up visit including clinical, biological evaluation (NYHA status, 6-min walking test, BNP) of the patients will be performed with an additional transthoracic echocardiography at 6 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Pessac, Francia, 33604
- Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor
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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:
- Adult (aged 18 or above)
- Sinus rhythm
- Patient must have signed informed consent
- Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
- Patient eligible for implantation of a ventricular resynchronization device or patient with a ventricular resynchronization device having a procedure of ventricular tachycardia ablation
- Left ventricular ejection fraction <35%
- NYHA Class II to IV with optimal medical treatment
- Patient covered by national healthcare insurance
Exclusion Criteria:
- Pregnant woman
- Sequel of transmural myocardial infarction
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intraventricular Electrical Activation
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Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the Left Ventricle (LV) cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Evolution of the Global Left Ventricle activation time (LVATG) with and without Cardiac Resynchronization Therapy (CRT).
Periodo de tiempo: Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Number, area and location of line of conduction block in the Left Ventricle
Periodo de tiempo: Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Area of the latest activated region of the Left Ventricle
Periodo de tiempo: Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Number, area and location of LV region activated after the end of surface QRS
Periodo de tiempo: Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Septal activation time (LVTAS)
Periodo de tiempo: Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Global intra-Left Ventricular dispersion time
Periodo de tiempo: Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Determination of the electrical parameters associated with good clinical response to CRT at 6 months.
Periodo de tiempo: 6 months after CRT device implantation
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6 months after CRT device implantation
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Non-invasive mapping: Same criteria evaluated non-invasively using CardioInsight ® with and without Cardiac Resynchronization Therapy activated.
Periodo de tiempo: Between 3 to 7 days after CRT device implantation
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Between 3 to 7 days after CRT device implantation
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHUBX 2010/29
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