Ensayo de eficacia de la ablación quirúrgica de la FA (SAFE)
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Atrial fibrillation (AF) affects more than 1% of the general population and is an important risk factor for stroke. AF prevalence increases with age, occurring in 10 to 15% of patients older than 80 years of age, which is important with the aging population. Of patients undergoing cardiac surgery, 10.8% have a history of AF. AF is believed to cause the left atrium to dilate and lose its transport function. AF significantly increases the risk of ischemic stroke of cardioembolic origin, but is also associated with heart failure and impairs quality of life. Although the causal relationship between the 2 clinical entities has not been fully elucidated, AF is believed to cause heart failure via several mechanisms.
Ablation of AF is the application of scars to the atrial tissue to disrupt faulty electrical signals that cause the arrhythmia. If surgical ablation of AF yields a benefit similar to catheter-based AF ablation, thousands of people undergoing cardiac surgery could benefit from this procedure each year. SAFE will be a landmark trial in cardiac surgery, definitely establishing surgical AF ablation's impact on cardiovascular outcomes. Cardiac surgery is the optimal setting to establish whether maintenance of sinus rhythm through AF ablation yields clinical benefit, and is a setting where sham-control is possible. This will not only provide evidence for the cardiac surgical patients but will bolster the evidence for ablation (catheter or stand-alone surgical) in other AF patients.
The intervention under investigation is concomitant surgical AF ablation which is compared to no surgical AF ablation. The primary outcome is hospital readmissions with heart failure during 4 years of follow-up. This study will enroll 2000 patients from 50 centres, globally. Patients will be followed at hospital discharge, 4 to 6 weeks after surgery, 6 months after surgery, and then at 6-month intervals until the final follow-up visit, for a median follow-up for 4 years.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Richard Whitlock
- Número de teléfono: 905-521-2100
- Correo electrónico: Richard.Whitlock@phri.ca
Copia de seguridad de contactos de estudio
- Nombre: SAFE Coordinators
- Correo electrónico: SAFE@phri.ca
Ubicaciones de estudio
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Ontario
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Hamilton, Ontario, Canadá, L8L 2X2
- Reclutamiento
- Hamilton General Hospital
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Contacto:
- Richard Whitlock, MD PhD FRCSC
- Número de teléfono: 40306 905-527-4322
- Correo electrónico: richard.whitlock@phri.ca
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Investigador principal:
- Richard Whitlock, MD MSc FRCSC
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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;
- Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof;
- Documented history of paroxysmal or persistent AF
- Provide informed consent
Exclusion Criteria:
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Dominant atrial arrhythmia is atrial flutter;
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Documented left atrial diameter ≥ 6 cm;
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Previous cardiac surgery requiring opening of the pericardium;
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Patients undergoing any of the following procedures:
- Heart transplant
- Complex congenital heart surgery
- Sole indication for surgery is ventricular assist device insertion
- Mitral valve repair or replacement
- Tricuspid valve repair or replacement
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Patient resides in a long-term care facility
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Surgical Atrial Fibrillation Ablation Group
Surgeon will perform left atrial ablation during patient's cardiac surgery procedure. |
Surgeon will preform surgical atrial fibrillation ablation using either cryoablation or bipolar radiofrequency clamps including 2 layers of atrium or vein, a minimum of 2 burns per clamping with at least 3 lines in the ablation group. Cavo-tricuspid isthmus and mitral lines will be allowed. |
|
Sin intervención: No Surgical Atrial Fibrillation Ablation Group
Surgeon will not perform left atrial ablation during the patient's cardiac surgery procedure. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of hospital readmissions for heart failure over duration of follow-up
Periodo de tiempo: Common termination point for trial (median follow-up of 4 years)
|
Total number of hospital readmissions for heart failure. |
Common termination point for trial (median follow-up of 4 years)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Ischemic stroke or systemic arterial embolism events over duration of follow up
Periodo de tiempo: Common termination point for trial (median follow-up of 4 years)
|
Number of Ischemic stroke or systemic arterial embolism events over duration of follow up |
Common termination point for trial (median follow-up of 4 years)
|
|
Length of ICU stay
Periodo de tiempo: From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
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Length of ICU stay, including readmissions, from study intervention surgery to hospital discharge, including readmissions |
From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
|
Length of hospital stay
Periodo de tiempo: From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
Length of hospital stay |
From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
|
Freedom from recurrence of atrial tachyarrhythmia
Periodo de tiempo: 1 year post-operatively
|
Freedom from recurrence of atrial tachyarrhythmia |
1 year post-operatively
|
|
Number of days free from admission to healthcare facility or presentation to the emergency department for heart failure
Periodo de tiempo: Common termination point for trial (median follow-up of 4 years)
|
Number of days free admission to healthcare facility or presentation to the emergency department for heart failure |
Common termination point for trial (median follow-up of 4 years)
|
|
All-cause mortality
Periodo de tiempo: Common termination point for trial (median follow-up of 4 years)
|
All-cause mortality |
Common termination point for trial (median follow-up of 4 years)
|
|
Cardiovascular mortality
Periodo de tiempo: Common termination point for trial (median follow-up of 4 years)
|
Cardiovascular mortality |
Common termination point for trial (median follow-up of 4 years)
|
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Antiarrhythmic drug use
Periodo de tiempo: Beyond 6 weeks until common termination point for trial (median follow-up of 4 years)
|
Antiarrhythmic drug use |
Beyond 6 weeks until common termination point for trial (median follow-up of 4 years)
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|
Number of patients undergoing atrial fibrillation ablation
Periodo de tiempo: 90 days post- study surgery until common termination point for trial (median follow-up of 4 years)
|
Number of patients undergoing atrial fibrillation ablation |
90 days post- study surgery until common termination point for trial (median follow-up of 4 years)
|
|
Quality of Life - atrial fibrillation specific
Periodo de tiempo: At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Atrial fibrillation specific quality of life as assessed by the Atrial Fibrillation Effect on QualiTy of Life questionnaire (AFEQT) which is 20 questions using a 7 point Likert scale where a higher score means a worse outcome. |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Quality of Life - heart failure specific
Periodo de tiempo: At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Heart failure specific quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) which is a 12 questions using Likert scales where a higher score is a better outcome. |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Quality of Life - General
Periodo de tiempo: At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Quality of life- general as assessed by the European quality of life index version 5D (EQ-5D-5L) which consists of a descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Ischemic stroke and systemic arterial embolism
Periodo de tiempo: Up to 30 days post-operatively
|
Safety outcome |
Up to 30 days post-operatively
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Number of patients requiring permanent pacemaker implantation
Periodo de tiempo: Up to 1 year post-operatively
|
Safety outcome |
Up to 1 year post-operatively
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Volume of chest tube output
Periodo de tiempo: Up to 24 hours post-operatively
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Safety outcome - chest tube output measured in mL. |
Up to 24 hours post-operatively
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Re-operation for bleeding
Periodo de tiempo: From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
Safety outcome |
From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
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All-cause mortality
Periodo de tiempo: Prior to discharge or within 30 days post-operatively (whichever occurs first)
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Safety outcome |
Prior to discharge or within 30 days post-operatively (whichever occurs first)
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Post-operative major bleeding
Periodo de tiempo: <48 hours after surgery
|
Safety outcome |
<48 hours after surgery
|
|
Number of patients with pulmonary vein stenosis
Periodo de tiempo: At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Safety outcome |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Number of patients with stiff left atrium syndrome
Periodo de tiempo: At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Safety outcome |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Number of patients with esophageal to atrial fistula
Periodo de tiempo: At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Safety outcome |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
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Health economic analysis of surgical atrial fibrillation
Periodo de tiempo: At 1 year, and at common termination point (median follow-up of 4 years)
|
Economic analysis will be assessed via health care utilization by patients |
At 1 year, and at common termination point (median follow-up of 4 years)
|
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Health economic analysis of surgical atrial fibrillation
Periodo de tiempo: At 1 year, and at common termination point (median follow-up of 4 years)
|
Economic analysis will be assessed via a questionnaire of health care visits and costs incurred by patients. |
At 1 year, and at common termination point (median follow-up of 4 years)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Richard Whitlock, Population Health Research Institute
- Investigador principal: Emilie Belley-Côté, Population Health Research Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SAFEV1.0
Información sobre medicamentos y dispositivos, documentos del estudio
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