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The Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation

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Qué se está recopilando

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Recopilados desde hoy en adelante - Prospectivo
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Quiénes están siendo reclutados

Fibrilación Auricular+4

+ Arritmias Cardíacas

+ Enfermedades Cardiovasculares

A partir de 18 años
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Cómo está diseñado el estudio

Cohorte

Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.
Observacional
Inicio del estudio: noviembre de 2021
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Resumen

Patrocinador PrincipalShanghai 10th People's Hospital
Contacto del EstudioDongdong ZhaoMás contactos
Última actualización: 28 de enero de 2026
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Fecha de inicio: 10 de noviembre de 2021

Fecha en la que se inscribió al primer participante.

1. Study aim. This study was designed to measure the left and right atrial pressure change before and after catheter ablation (CA) and left atrial appendage closure (LAAC) combining procedure, and investigate the influence of the pressure change on clinical outcomes. 2. Subject selection. This study is designed to recruit patients diagnosed with atrial fibrillation and planned to undergo combined procedure. Primary inclusion criteria are: i. Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; ii. Eligible for left atrial appendage closure, that meet at least one of the followings: 1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3); 2. Contraindicated to oral anticoagulation (OAC); 3. Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment. 3. Procedure detail. All the patients recruited is planned to undergo combined procedure. CA is performed before LAAC. For CA, the energy source is optional (either radiofrequency or cryoenergy). And ablation should be performed for pulmonary vein isolation only. For LAAC, the occluder type is optional (either plug or pacifier occluder), and intracardiac echocardiography or transesophageal echocardiography (TEE) is optional. For atrial pressure measurement, right atrial pressure should be measured before transseptal puncture and after combined procedure is accomplished. Left atrial pressure should be measured at 3 timepoints: after transseptal puncture, after pulmonary vein isolation and after LAAC. Atrial pressure is measured via Swartz transseptal puncture sheath. And at each timepoint, atrial pressure should be recorded at 1min, 3min, and 5min after the placement of the sheath. 4. Follow-up. study endpoint includes a primary composite endpoint of rehospitalization due to heart failure and death due to cardiovascular disease, and secondary endpoints including: 1. all-cause mortality 2. major cardiovascular adverse event 3. rehospitalization due to cardiovascular diseases 4. recurrence of atrial arrhythmia 5. stoke/transient ischemic attack 6. echocardiographic measurement 7. quality of life evaluation 8. cardiac function evaluation 9. evaluation of left atrial appendage closure. Patients are required to have outpatient follow-up at 3rd month, 12th month, and every year since then. The anti-thromboembolic regimen should follow: 3-month OAC treatment and 3-month double anti-platelet therapy and lifelong single anti-platelet therapy. For LAAC follow-up, either TEE or CTA is scheduled to perform in the 3rd month after procedure.

Título OficialThe Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation
NCT05106270
Patrocinador PrincipalShanghai 10th People's Hospital
Contacto del EstudioDongdong ZhaoMás contactos
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

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Detalles del Diseño

Se reclutarán 100 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Cohorte

Estos estudios siguen a un grupo de personas con características comunes (como una condición o año de nacimiento) durante un periodo específico para analizar resultados de salud o exposiciones.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Fibrilación AuricularArritmias CardíacasEnfermedades CardiovascularesEnfermedades del CorazónInsuficiencia CardíacaProcesos PatológicosCondiciones Patológicas, Signos y Síntomas

Criterios

Inclusion Criteria: * Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; * Eligible for left atrial appendage closure, that meet at least one of the followings: 1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3); 2. Contraindicated to oral anticoagulation (OAC); 3. Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment. * Capable of understanding and signing the informed consent form. * Aged over 18 years. Exclusion Criteria: * Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication; * Concomitant arrhythmia including atrial flutter, ventricular tachycardia; * A previous history of atrial fibrillation surgery (MAZE surgery) or catheter ablation; * A previous history of cardiac surgery including any valvular replacement, septal repair; * A recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation; * A history of congenital heart disease; * A previous history of atrioventricular node ablation; * A history of lobectomy due to any medical condition; * Complicated by other diseases with life expectation \<1 year; * Women with childbearing potential; * Participated in other interventional clinical trials that might affect prognosis; * Unable to understand or give informed consent form.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

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Department of Cardiology, Shanghai Tenth People's Hospital

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