Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion

Study Overview
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Brief Summary
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A total of 75 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into 3 groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography and fluoroscope only respectively (allocation ratio 1:1:1). 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 and fluoroscopy only 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]). The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided and fluoroscopy only-guided left atrial appendage occlusion combined with radiofrequency ablation. The average follow-up time is 3 months.

Official Title
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Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: LAAC combined with radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 and HAS-BLED score ≥3, 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transesophageal echocardiography guidance<br> | Procedure: LAAC combined with radiofrequency ablation<br>* Each patient received the same group of patients with simple radiofrequency ablation and LAAC<br>|
| Experimental: intracardiac echocardiography guidance<br> | Procedure: LAAC combined with radiofrequency ablation<br>* Each patient received the same group of patients with simple radiofrequency ablation and LAAC<br>|
| Experimental: fluoroscopy only guidance<br> | Procedure: LAAC combined with radiofrequency ablation<br>* Each patient received the same group of patients with simple radiofrequency ablation and LAAC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| injected contrast media | milliliter | in the procedure | 
| fluoroscopy time were recorded | mGy | in the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time from femoral vein puncture to transseptal puncture to closure were recorded | second | in the procedure | 
| The size of the LAA | millimeter | in the procedure | 
| the size of the selected umbrella in operation | millimeter | in the procedure | 
| residual shunt and DRT after transcatheter closure of left atrial appendage detected | Transesophageal echocardiography | before operation and 3 months after operation | 
| new pericardial effusion were detected | Transthoracic echocardiography | 3 months after operation | 
| pericardial tamponade were detected | Transthoracic echocardiography | 3 months after operation |