Intracardiac Versus Transesophageal Echocardiography for Left Atrial Appendage Occlusion Combined With Radiofrequency Ablation

Study Overview
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Brief Summary
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A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. All patients underwent transesophageal echocardiography before and 3 months after operation, and the results were explained by two experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. All patients were examined by transthoracic echocardiography 3 months after operation to evaluate new pericardial effusion, pericardial tamponade, instrument embolization / displacement and so on. The baseline clinical and surgical features and hospitalization outcomes of patients guided by ICE and TEE were recorded and compared. Clinical endpoints include death, new pericardial effusion that does not require pericardiocentesis, tamponade with pericardiocentesis, instrument embolism / displacement, bleeding at the entry site, thromboembolic events (stroke / transient ischemic attack [TIA]), and renal failure requiring dialysis. The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided left atrial appendage occlusion combined with radiofrequency ablation. And try to analyze whether intracardiac echocardiography can be used as an alternative to transesophageal echocardiography in transcatheter closure of left atrial appendage. The average follow-up time was 1 year.

Official Title
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Intracardiac Versus Transesophageal Echocardiography for Left Atrial Appendage Occlusion Combined With Radiofrequency Ablation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: LAAC combined with radiofrequency ablation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sustained AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2, not suitable for long-term oral anticoagulant drugs. 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 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography respectively (allocation ratio 1:1).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transesophageal echocardiography guidance<br> | Procedure: LAAC combined with radiofrequency ablation group<br>* 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>|
| Experimental: intracardiac echocardiography guidance<br> | Procedure: LAAC combined with radiofrequency ablation group<br>* 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 |
| --- | --- | --- |
| injected contrast media as well as fluoroscopy time were recorded | injected contrast media as well as fluoroscopy time were recorded in all patients | in the procedure | 
| the time from femoral vein puncture to transseptal puncture to closure were recorded | the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients | in the procedure | 
| residual shunt and DRT after transcatheter closure of left atrial appendage detected | Transesophageal echocardiography | 1-12months | 
| new pericardial effusion, pericardial tamponade were detected | Transthoracic echocardiography | 1-12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transesophageal echocardiography, intracardiac echocardiography, left atrial appendage closure combined with radiofrequency ablation, atrial fibrillation