Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB (TRAP-AF)
11 de septiembre de 2026 actualizado por: Ruijin Hospital
A Single-Center, Randomized, Open-Label Study of Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB
Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass surgery and may be associated with prolonged hospitalization and adverse cardiovascular outcomes. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that delivers mild electrical stimulation to the ear and may help regulate autonomic and inflammatory responses.
This randomized controlled trial will evaluate whether perioperative taVNS can reduce the incidence of POAF in adults undergoing elective off-pump coronary artery bypass grafting (OPCAB). Participants will be randomly assigned in a 1:1 ratio to receive either taVNS in addition to standard perioperative care or standard perioperative care alone. The primary outcome is the incidence of new-onset atrial fibrillation within 7 days after surgery. Secondary outcomes will include atrial fibrillation burden, inflammatory markers, heart rate variability, use of antiarrhythmic and anticoagulant medications, safety, length of hospital stay, and major adverse cardiovascular events during follow-up.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
410
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.
Estudio Contacto
- Nombre: Yanjun Sun, M.D.
- Número de teléfono: +8613918484784
- Correo electrónico: syj11595@rjh.com.cn
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 18 years or older.
- Scheduled to undergo elective off-pump coronary artery bypass grafting (OPCAB) for coronary artery disease with multivessel coronary artery disease.
- Sinus rhythm on the preoperative baseline electrocardiogram, with no history of atrial fibrillation or other clinically significant arrhythmias.
- Able and willing to provide written informed consent and comply with the study intervention and follow-up procedures.
- Expected postoperative hospital stay of at least 7 days to allow postoperative atrial fibrillation monitoring.
Exclusion Criteria:
- History of atrial fibrillation or other arrhythmias requiring antiarrhythmic therapy.
- Emergency OPCAB surgery or intraoperative conversion to on-pump coronary artery bypass grafting.
- Concomitant cardiac surgery, such as valve surgery, or hybrid cardiac procedures.
- Vagus nerve-related disorders, epilepsy, active ear infection, or implanted electrical devices such as a pacemaker or implantable cardioverter-defibrillator.
- Severe comorbidities, including severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²), active malignancy, current immunosuppressive therapy, or chronic inflammatory disease.
- Inability to tolerate auricular stimulation, including significant skin allergy or intolerance, or anticipated poor adherence to the study procedures.
- Expected survival of less than 12 months or inability to complete follow-up.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: taVNS Plus Standard Care
Participants assigned to this arm will receive perioperative transcutaneous auricular vagus nerve stimulation (taVNS) in addition to standard perioperative care for off-pump coronary artery bypass grafting.
|
Transcutaneous auricular vagus nerve stimulation (taVNS) will be delivered using the taVNS device.
Stimulation will be applied to the left auricular region targeting the auricular branch of the vagus nerve.
The stimulation frequency will be 20 Hz with a pulse width of approximately 200 μs.
Stimulation intensity will be gradually increased from zero to the highest level that is comfortably tolerated without pain.
Participants will receive two stimulation sessions per day, separated by at least 4-6 hours, beginning 1 days before surgery and continuing through postoperative day 7.
Each session will last 60 minutes.
Standard perioperative care for off-pump coronary artery bypass grafting will be provided concurrently.
|
|
Sin intervención: Standard Care
Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
Periodo de tiempo: From the end of surgery through postoperative day 7
|
The proportion of participants who develop new-onset postoperative atrial fibrillation (POAF) after off-pump coronary artery bypass grafting.
POAF is defined as an episode of atrial fibrillation lasting at least 30 seconds, detected by continuous electrocardiographic monitoring, Holter monitoring, or telemetry.
Events will be adjudicated by outcome assessors blinded to treatment allocation.
|
From the end of surgery through postoperative day 7
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Duration of Postoperative Atrial Fibrillation
Periodo de tiempo: From the end of surgery through postoperative day 7
|
Total duration of postoperative atrial fibrillation episodes detected by continuous electrocardiographic monitoring during the first 7 days after surgery.
|
From the end of surgery through postoperative day 7
|
|
Change in Circulating Inflammatory Markers
Periodo de tiempo: Baseline and postoperative 24, 72 and 120 hours
|
Changes in serum interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP) levels will be assessed to evaluate the perioperative inflammatory response.
|
Baseline and postoperative 24, 72 and 120 hours
|
|
Heart Rate Variability
Periodo de tiempo: From the end of surgery through postoperative day 7
|
Heart rate variability will be assessed using Holter monitoring, including SDNN and RMSSD as measures of autonomic function.
|
From the end of surgery through postoperative day 7
|
|
Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation
Periodo de tiempo: Through postoperative day 7
|
Proportion of participants requiring antiarrhythmic medication for treatment of postoperative atrial fibrillation, including drugs such as amiodarone.
|
Through postoperative day 7
|
|
Initiation of Anticoagulation for Postoperative Atrial Fibrillation
Periodo de tiempo: Through postoperative day 7
|
Proportion of participants in whom anticoagulant therapy is initiated because of postoperative atrial fibrillation.
|
Through postoperative day 7
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de octubre de 2027
Finalización del estudio (Estimado)
1 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Publicado por primera vez (Actual)
17 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025575
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Deidentified individual participant data that underlie the results reported in the primary publication may be shared with qualified researchers upon reasonable request.
Requests will be reviewed by the study investigators and will require a methodologically sound proposal and appropriate data-use agreements.
Data sharing will be subject to applicable ethical, institutional, and privacy requirements.
Marco de tiempo para compartir IPD
Beginning 6 months after publication of the primary study results and remaining available for 5 years.
Criterios de acceso compartido de IPD
Deidentified individual participant data and the specified supporting information will be made available to qualified researchers who submit a methodologically sound proposal for scientifically valid analyses.
Requests will be reviewed by the principal investigator and study team.
Access will be granted subject to applicable institutional, ethical, and privacy requirements and, where appropriate, completion of a data-use agreement.
Data will be provided only for the purposes approved in the request.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .