Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy (PEGASUS CRT)

20 de diciembre de 2011 actualizado por: Boston Scientific Corporation

Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy

This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.

Descripción general del estudio

Descripción detallada

PEGASUS CRT is a multicenter trial that will assess the effect of a cardiac resynchronization therapy defibrillator (CRT-D) device programmed to DDD-70 or DDDR-40 compared to a CRT device programmed to DDD-40 in heart failure patients. The effect of atrial support pacing in heart failure patients will be assessed using a clinical composite rating. A sub-study will evaluate the effect pacing mode has on exercise capacity in this heart failure population.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1742

Fase

  • Fase 4

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.

Ubicaciones de estudio

    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • The Cleveland Clinic Hospital

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 who meet current indications for the CONTAK RENEWAL® family of cardiac resynchronization therapy defibrillator (CRT-D) devices or future Food and Drug Administration (FDA) approved Guidant CRT-D devices
  • Patients who sign and date a Patient Informed Consent at, or prior to, the implant visit
  • Patients who are in sinus rhythm at the time of implant
  • Patients who remain in the clinical care of the enrolling physician in approved centers
  • Patients who are on optimal pharmacologic therapy or who have developed a recent implantable cardioverter defibrillator (ICD) indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy

Exclusion Criteria:

  • Patients whose medical condition is expected to preclude the use of the protocol-required pacing mode (dual chamber pacing [DDD or DDDR]) and respective lower rate limits
  • Patients with permanent atrial fibrillation or atrial flutter
  • Patients who are in complete heart block
  • Patients who have previously had a pacemaker, ICD, or CRT device
  • Patients whose life expectancy is less than 12 months due to other medical conditions
  • Patients who are expected to receive a heart transplant during the duration of the study
  • Patients who have other cardiac surgeries or procedures planned but not yet performed
  • Patients who currently have or who are likely to receive a tricuspid valve prosthesis
  • Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study.
  • Patients who are younger than 18 years of age
  • Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
  • Patients who are or become pregnant

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 paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: DDD-40
DDD-40 for this trial is the comparator arm. Even though patients are receiving a CRT-D device, atrial support pacing in this arm will be limited as the device will not pace unless the rate falls below 40 bpm.
All subjects in this trial receive the same device. For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.
Comparador activo: DDDR-40
DDDR-40 programming will initiate atrial support pacing if the rate falls below 40 bpm or if atrial support is needed in response to increased activity.
All subjects in this trial receive the same device. For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.
Comparador activo: DDD-70
Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm.
All subjects in this trial receive the same device. For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical Composite Score
Periodo de tiempo: From randomization (6-weeks) through 12-month visit
The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association [NYHA] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.
From randomization (6-weeks) through 12-month visit

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Quality of Life
Periodo de tiempo: From randomization (6-weeks) through 12-month visit
Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.
From randomization (6-weeks) through 12-month visit
Change in Self Assessed Physical Activity
Periodo de tiempo: From randomization (6-weeks) through 12-month visit
Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.
From randomization (6-weeks) through 12-month visit

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: David O. Martin, MD, MPH, The Cleveland Clinic
  • Investigador principal: John Day, Utah Heart Clinic, LDS Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 diciembre de 2004

Finalización primaria (Actual)

1 de enero de 2009

Finalización del estudio (Actual)

1 de febrero de 2009

Fechas de registro del estudio

Enviado por primera vez

2 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

6 de septiembre de 2005

Publicado por primera vez (Estimar)

7 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

28 de diciembre de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

20 de diciembre de 2011

Última verificación

1 de diciembre de 2011

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CR-CA-100604-H
  • PEGASUS

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Insuficiencia cardiaca

3
Suscribir