Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)

Study Overview
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Brief Summary
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The study is a prospective, randomized, single-blind clinical trial aiming to compare two method in guidance of Vein of Marshall ethanol infusion (VOMEI), i.e., the conventional fluoroscopy-guided VOMEI and UNIVU-guided VOMEI.

Detailed Description
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A total of 100 participants with persistent or longstanding persistent AF who undergo radiofrequency catheter ablation will be randomized assigned to two groups at 1:1 ratio to receive Vein of Marshall ethanol infusion (VOMEI). Group 1: VOMEI guided by fluroscopy alone Group 2: VOMEI guided by fluoroscopy and CARTO UNIVU The intraprocedural major endpoints are the change in low-voltage area led by VOMEI (efficacy endpoint) and procedural complications (safety endpoint). The longterm major endpoint is the recurrence of atrial tachyarrhythmia between 3 and 12 months.

Official Title
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Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation

Conditions
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Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Vein of Marshall ethanol infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 85 years Sympathetic atrial fibrillation without previous ablation Persistent or long-standing persistent AF Patients' willing to undergo catheter ablation and VOMEI Exclusion Criteria: Left atrial or left atrial appendage thrombus LVEF <30% Cardiac surgery within 90 days Myocardial infarction within 90 days PCI or PTCA within 90 days Thromboembolic events within 90 days, including stroke, pulmonary embolism, systemic embolism Atrial myxoma Congenital heart disease Pregnant or pregnant plan Acute or severe infection Creatine> 221 μmol/L, or GFR <30 ml/min/1.73 m. Unstable angina Blood-clotting or bleeding disorder Contraindication to anticoagulation Life expectancy less than 1 year Uncontrolled heart failure Uncontrolled malignant tumor Malformation of femoral vascular access Without consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluoroscopy-guided VOMEI<br>Vein of Marshall ethanol infusion guided by fluoroscopy alone | Procedure: Vein of Marshall ethanol infusion<br>* Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.<br>|
| Experimental: UNIVU-guided VOMEI<br>Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy | Procedure: Vein of Marshall ethanol infusion<br>* Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of low-voltage or scar area before and after VOMEI | Left atrial voltage mapping will be performed before and after VOMEI. The low-voltage area or scar area will be mesured and compared before and after VOMEI | During the procedure | 
| Procedural complications | Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death. | within 72 hours | 
| Recurrence of atrial tachyarrhythmias | Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia | 3 to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of mitral isthmus block | bidirectional block of mitral isthmus | During the procedure | 
| New low-voltage or scar area outside mitral isthmus and left pulmonary ridge | New low-voltage or scar area after VOMEI outside the targeted regions | During the procedure | 
| Rates of VOMEI incomplete | Any reason leading to incomplete VOMEI | During the procedure | 
| X ray exposure time | Procedure-related temporal parameters | During the procedure | 
| procedure time | Procedure-related temporal parameters | During the procedure | 
| radiofrequency ablation time | Procedure-related temporal parameters | During the procedure | 
| Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion) | Termination of atrial fibrillation without cardioversion | During the procedure | 
| Burden of atrial tachyarrhythmia | Evaluation by Holder monitoring at 12 months | 12 months | 
| Recurrence of atrial flutter | recurrence of atrial flutter > 30 second by ECG or Holder monitoring | 3 to 12 months | 
| Volume of ethanol and contrast agent used | ethanol volume, contrast agent volume used during the procedure | During the procedure |