Changes of Left Atrial Function and Quality of Life After Transcatheter Closure of Left Atrial Appendage in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      A total of 105 (AF) patients with atrial fibrillation are scheduled to undergo surgery and
      will be divided into three groups. Left atrial appendage occlusion ((LAAC)), radiofrequency
      ablation guided by three-dimensional mapping and LAAC combined with radiofrequency ablation
      were performed respectively (allocation ratio 1:1:1). All patients were examined by real-time
      three-dimensional and two-dimensional ultrasound before operation and 3, 6 and 12 months
      after operation, and the (LA) function of left atrium was measured. All ultrasound data will
      be stored and the professional director of the ultrasound room will be invited to conduct
      quantitative analysis. Ultrasonic examination indexes include: anterior and posterior
      diameter of left atrium, left atrial ejection fraction and so on. All patients underwent
      transesophageal echocardiography before and 3 months after operation. The results were
      interpreted by 2 experienced ultrasound doctors to measure the presence of left atrial
      thrombus, residual shunt and device-related thrombus. Blood samples were taken to detect
      B-type natriuretic peptide before operation, 1 day, 3-6 months and 12 months after operation.
      All patients underwent 6-minute walking test and quality of life score before operation and
      3, 6 and 12 months after operation. At the same time, the thickness of crest in all patients
      was measured during operation. This study will clarify the changes of left atrial function
      and quality of life in patients with atrial fibrillation after LAAC. In addition, this study
      also observed the effect of radiofrequency ablation combined with LAAC on left atrial
      function and evaluated whether one-stop surgery was superior to simple occlusion or ablation,
      and the above results were analyzed. The patients were followed up for an average of one
      year, and the changes of left atrial function, quality of life and embolic events were
      analyzed.
    


Intervention name(s): Left atrial appendage closure; Radiofrequency ablation; LAAC combined with radiofrequency ablation group
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography; Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.; Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 105 patients with persistent atrial fibrillation(AF), who are persistented more than one year and planned to undergo surgical treatment, will be allocated into two groups. These patients will receive left atrial appendage closure, radiofrequency ablation under the guidance of 3D mapping and left atrial appendage closure combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atrial fibrillation; left atrial appendage closure; left atrial function; quality of life