Pacing for Heart Failure With Preserved Ejection Fraction (HFpEF)
29 de mayo de 2013 actualizado por: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure.
This new pacing method may allow the heart to pump more efficiently.
Participation in this study will last approximately 8 months.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients with an EF greater than 50% and a regional mechanical delay of >= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature.
When the feature is active, the device wil pace the left ventricle to target improved pump efficiency.
Patients will have the feature active for 4 months and inactive for 4 months.
The order will be randomized and the patient will not know whether the pacing is active or not.
Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients with quantitative ejection fraction (EF) of greater than 50 percent
- Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
- Patients greater than 18 years of age
- Patients willing and able to give informed consent
- Patients available for appropriate follow-up times for the length of study
- Patients able to complete cardiopulmonary exercise (CPX) testing
- Patients expected lifespan is greater than 12 months beyond study enrollment
- Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds
Exclusion Criteria:
- Patients who have undergone cardiac surgery 60 days prior to enrollment
- Patients who have had a myocardial infarction 90 days prior to enrollment
- Patients with hemodynamically significant uncorrected cardiac valvular disease
- Patients with active myocarditis and amyloidosis (if documented)
- Patients with a permanent pacemaker
- Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
- Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
- Patients with a PR interval greater than 250 milliseconds
- Patients with severe chronic obstructive pulmonary disease
- Patients with high risk coronary artery disease
- Patients who are or expect to become pregnant during this study
- Patients enrolled in concurrent studies which could confound the results of this study
- Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
- Patients with infiltrative disease or restrictive cardiomyopathy
- Patients with indication for percutaneous coronary intervention (PCI) at enrollment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Fusion Pacing OFF
Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF.
At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm.
|
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Otros nombres:
|
|
Experimental: Fusion Pacing ON
Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON.
At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm.
|
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of adverse events while the Fusion Pacing download is active vs. inactive.
Periodo de tiempo: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.
Periodo de tiempo: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in Minnesota Living with Heart Failure Questionnaire score.
Periodo de tiempo: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).
Periodo de tiempo: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.
Periodo de tiempo: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in NT-proBNP.
Periodo de tiempo: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: HFpEF Trial Leader, Medtronic
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2010
Finalización primaria (Actual)
1 de enero de 2013
Finalización del estudio (Actual)
1 de enero de 2013
Fechas de registro del estudio
Enviado por primera vez
8 de enero de 2010
Primero enviado que cumplió con los criterios de control de calidad
8 de enero de 2010
Publicado por primera vez (Estimar)
11 de enero de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de mayo de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2013
Última verificación
1 de mayo de 2013
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MDT0095101
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