An interventional study of Left atrial appendage closure and Radiofrequency ablation in Atrial Fibrillation, sponsored by Ruiqin xie. Completed at 1 site in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by Ruiqin xie · Not applicable, Interventional, and Treatment
A total of 105 patients with persistent atrial fibrillation(AF), that lasting longer than one year and planned to undergo surgical treatment, will be allocated into three groups. These patients will receive left atrial appendage closure(LAAC), radiofrequency ablation under the guidance of 3D mapping and LAAC combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1). Real-time 3D ultrasound and 2D ultrasound examinations and measurement of left ventricle(LV) and left atrial(LA) function are carried out for all patients before the operation, and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after the operation. All ultrasound data will be stored and a professional director from the ultrasound room will be invited for quantitative analysis. Indicators for ultrasonography include: LV ejection fraction(LVEF), LV end-diastolic volume, Stroke volume, left atrial anterior and posterior diameter, left atrial volume, left atrial volume index, mitral e ", E peak, A peak, velocity time integral (VTI), left atrial ejection fraction, left atrial strain, and strain rate. Blood samples are extracted in all patients to detect type B natriuretic peptide before the operation and at 1, 2, 3 days and 1,3,6,12 months after the operation. Blood samples are extracted in all patients to detect routine blood, coagulation, D-D dimmer,Inflammatory markers (hsCRP） and other biochemical parameters before the operation and at 1, 2, 3 and 4 weeks and 1, 2, 3,6and 12 months after the operation. At the same time in operation LA pressure in all patients will be measured preoperatively and postoperatively. This study will clarify the short-term and long-term changes of LA pressure and function of patients with persistent AF after LAAC, and whether changes in left atrial pressure and function are related to inflammation indicators. This study will also to observe whether the coagulation indexes changed after LAAC that can be used to know whether the LAAC activates the coagulation system. In addition, this study to investigate the effects of radiofrequency ablation combined with LAAC on left atrial pressure and function, changes of blood coagulation and inflammatory markers, and to analyze the above findings. At an average follow-up of one year, changes in left atrial function, inflammation, coagulation, and embolic events were analyzed early (3 months after surgery) and late (1 years after surgery).
Exclusion Criteria:
Procedure: Left atrial appendage closure
Procedure: Radiofrequency ablation
Procedure: LAAC combined with radiofrequency ablation group
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
Left atrial function of postoperative left atrial appendage occlusion detected
Transthoracic ultrasound
Time frame: 1-12 month
Plasma biomarkers of inflammation assessed
Blood samples are extracted in all patients for the detection of the C reactive protein, white blood cell，red blood cell, Platelets，neutrophile and lymphocytes.
Time frame: 1-12 month
B natriuretic peptide assessed
Blood samples are extracted in all patients to detected
Time frame: 1-12 month
Coagulation index assessed
Blood samples are extracted in all patients to detected
Time frame: 1-6 month
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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