Changes of Left Atrial Function and Quality of Life in Patients With Left Atrial Appendage Occlusion

Study Overview
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Brief Summary
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A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC), three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency ablation (1:1:1) were performed respectively. All patients were examined three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure left atrial (LA) function. The routine blood test and high-sensitivity C-reactive protein were performed in all patients before operation, 1 day and 1 month after operation. B-type natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute walking test and quality of life score before operation, 1 and 3 months after operation.

Detailed Description
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A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC), three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency ablation (1:1:1) were performed respectively. All patients were examined by real-time three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure left atrial (LA) function. All ultrasound data will be stored and the professional director of the ultrasound room will be invited for quantitative analysis. The ultrasound indexes include: left atrial diameter, left atrial ejection fraction, etc. All patients underwent transesophageal echocardiography before operation and 3 months after the operation. Results two experienced ultrasound doctors judged whether there was left atrial thrombus, residual shunt and instrument surface related thrombus. The routine blood test and high-sensitivity C-reactive protein were performed in all patients before operation, 1 day and 1 month after operation. B-type natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute walking test and quality of life score before operation, 1 and 3 months after operation. At the same time, the thickness of crista was measured in all patients. This study will clarify the changes of left atrial function and biochemical quality in patients with AF 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 has more advantages than simple occlusion or ablation, and analyzed the above results. The patients were followed up for an average of three months to analyze the changes of left atrial function, quality of life and embolism events.

Official Title
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Short Term Changes of Left Atrial Function and Quality of Life in Patients With Atrial Fibrillation After Left Atrial Appendage Occlusion

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Left atrial appendage closure group
* Procedure: Radiofrequency ablation group
* Procedure: LAAC combined with radiofrequency ablation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AF lasting for more than one year; Antiarrhythmic drugs are ineffective; Age of patients is less than 80 years old; Cha2ds2-vasc score ≥ 2; Not suitable for long-term oral anticoagulants. Exclusion Criteria: Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation); Patients undergoing prosthetic heart valve replacement; Pregnant women; Patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left atrial appendage closure group<br> | Procedure: Left atrial appendage closure group<br>* Left atrial appendage closure Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography<br>|
| Experimental: Radiofrequency ablation group<br> | Procedure: Radiofrequency ablation group<br>* Radiofrequency ablation 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.<br>|
| Experimental: LAAC combined with radiofrequency ablation group<br> | Procedure: LAAC combined with radiofrequency ablation group<br>* LAAC combined with radiofrequency ablation group 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left atrial function of postoperative left atrial appendage occlusion detected | Transthoracic ultrasound | 1- 3 month | 
| changes of 6-minute walking test | 6-minute walking test in meter | 1- 3 month | 
| quality of life assessed | Shot Form 36 Health Survey Questionnaire：the higher the patient's score, the better the quality of life | 1- 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual shunt after transcatheter closure of left atrial appendage detected | Transesophageal ultrasound | 1-3 month | 
| device-related thrombus after transcatheter closure of left atrial appendage detected | Transesophageal ultrasound | 1-3 month | 
| C creative protein | Blood samples are extracted in all patients to detected | 1-3 month | 
| B natriuretic peptide assessed | Blood samples are extracted in all patients to detected | before and 3 month after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, left atrial appendage closure, quality of life assessed, left atrial function