Efficacy of Early Rhythm Control in AF With TR Patients (TRAF)
Descripción general del estudio
Estado
Descripción detallada
Atrial fibrillation and tricuspid regurgitation frequently coexist in clinical practice. Atrial fibrillation may promote right atrial enlargement and tricuspid annular dilatation, which can aggravate functional tricuspid regurgitation over time. Conversely, significant tricuspid regurgitation may further increase right-sided volume overload, worsen atrial remodeling, and contribute to the persistence or progression of atrial fibrillation. This bidirectional relationship may lead to heart failure, thromboembolic events, and an increased need for tricuspid valve intervention.
Although early rhythm control has been shown to improve cardiovascular outcomes in selected patients with atrial fibrillation, its clinical benefit in patients with concomitant tricuspid regurgitation has not been well established. In particular, it remains uncertain whether maintaining sinus rhythm at an early stage can slow the progression of right-sided cardiac remodeling, reduce heart failure events, and improve long-term prognosis in this population.
This study is designed to evaluate the prognostic impact of early rhythm control compared with usual care in patients with atrial fibrillation and tricuspid regurgitation. The primary endpoint will be a composite of cardiac death, heart failure admission, stroke, and tricuspid valve surgery. By comparing these clinically meaningful outcomes between the two treatment strategies, this study aims to clarify whether early rhythm control should be considered as an active therapeutic approach in patients with atrial fibrillation complicated by tricuspid regurgitation.
The study will use retrospectively collected data from patients diagnosed with atrial fibrillation and tricuspid regurgitation between January 1, 2013 and December 31, 2023. Clinical outcomes will be assessed during this observation period.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ju Youn Kim, Ph.D
- Número de teléfono: 82+ 10-5482-7307
- Correo electrónico: kzzoo921@gmail.com
Ubicaciones de estudio
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Seoul
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Seoul, Seoul, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
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Contacto:
- Ju Youn Kim, Ph.D
- Número de teléfono: 82+ 2-3410-3419
- Correo electrónico: kzzoo921@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
The investigator emulated a sequential target trial comparing early rhythm control with usual care among patients with atrial fibrillation and tricuspid regurgitation, using data from the Korean National Health Insurance Service (K-NHIS) claims database.
The K-NHIS database represents the entire population of Korea. The K-NHIS database covers the total population of Korea. The NHIS database includes information on all individuals in Korea, such as demographics, diagnosis codes based on the International Classification of Diseases, 10th Revision (ICD-10), procedures, prescriptions (coded by ATC codes), utilization of healthcare services, and mortality linked to national statistics. The investigator further linked these data with the National Health Screening Program, which provides biennial standardized health examination results, including laboratory measurements such as serum creatinine and hemoglobin, using anonymized individual identifiers.
Descripción
Inclusion Criteria:
- Patients with concomitant atrial fibrillation and tricuspid regurgitation.
Exclusion Criteria:
- Patients with a history of valvular surgery
- Patients with congenital heart disease
- Patients with primary pulmonary hypertension
- Patients with CIED implantation prior to the diagnosis of tricuspid regurgitation
- Patients diagnosed with TR only after the initiation of rhythm control therapy for AF
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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early rhythm control group
Patients who received rhythm control therapy(include catheter ablation, cardioversion, anti-arrhythmic drugs) within 2 years of new-onset atrial fibrillation
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flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone
Direct-current cardioversion may be performed to acutely restore sinus rhythm, particularly in patients with persistent atrial fibrillation or symptomatic rhythm deterioration.
Catheter ablation may be considered as a more definitive rhythm-control strategy to reduce atrial fibrillation burden and maintain sinus rhythm over the long term.
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Usual care group
Patients who received usual care include rate control therapy without early rhythm control intervention within 2 years of new-onset atrial fibrillation
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General management without atrial fibrillation rhythm control treatment.(Observation
without additional medication, or heart rate control treatment if necessary)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery
Periodo de tiempo: From January 1, 2013 to December 31, 2023
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The incidence rate of the major clinical events Major clinical event is;
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From January 1, 2013 to December 31, 2023
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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All cause death
Periodo de tiempo: From January 1, 2013 to December 31, 2023
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The incidence rate of all-cause death during the observation period.
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From January 1, 2013 to December 31, 2023
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Cardiac death
Periodo de tiempo: From January 1, 2013 to December 31, 2023
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The incidence rate of cardiac death during the observation period.
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From January 1, 2013 to December 31, 2023
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Hospitalization for heart failure
Periodo de tiempo: From January 1, 2013 to December 31, 2023
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The incidence rate of hospitalization for heart failure during the observation period.
(admission due to worsening signs or symptoms of heart failure requiring medical treatment, including intravenous diuretics, inotropes, vasodilators, or other heart failure-directed therapy)
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From January 1, 2013 to December 31, 2023
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Stroke
Periodo de tiempo: From January 1, 2013 to December 31, 2023
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The incidence rate of stroke during the observation period.
(new neurological deficit of presumed vascular origin, including ischemic or hemorrhagic stroke, confirmed by clinical evaluation and/or brain imaging)
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From January 1, 2013 to December 31, 2023
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Tricuspid valve surgery
Periodo de tiempo: From January 1, 2013 to December 31, 2023
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The incidence rate of tricuspid valve surgery during the observation period.
(surgical or transcatheter intervention for tricuspid valve disease, including tricuspid valve repair or replacement)
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From January 1, 2013 to December 31, 2023
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Pacemaker implantation
Periodo de tiempo: From January 1, 2013 to December 31, 2023
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The incidence rate of pacemaker implantation during the observation period.
(new implantation of a permanent pacemaker during the observation period, including single-chamber or dual-chamber pacemaker implantation, when performed for clinically indicated bradyarrhythmia or conduction disease)
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From January 1, 2013 to December 31, 2023
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Colaboradores e Investigadores
Patrocinador
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
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Arritmias Cardiacas
- Enfermedades de las válvulas cardíacas
- Condiciones Patológicas, Signos y Síntomas
- Fibrilación auricular
- Insuficiencia de la válvula tricúspide
- Terapéutica
- Procedimientos quirúrgicos, operativo
- Técnicas de ablación
- Ablación por radiofrecuencia
- Terapia con radiofrecuencia
- Ablación del catéter
Otros números de identificación del estudio
- SMC 2025-05-075-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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