Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation

Study Overview
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Brief Summary
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The superior vena cava (SVC) is one of the most common non pulmonary vein (PV)-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency (RF)-ablation under close monitoring of the phrenic nerve. However, adding substrate modification and vein of Marshal (VoM) ethanol infusion to the ablation procedure might substantially improve long-term outcomes. The aim of this study is to evaluate the recurrence rate 1 year after the index ablation in patients undergoing a redo ablation for recurrent paroxysmal atrial fibrillation (PAF) despite durable pulmonary vein isolation (PVI) with either SVC isolation alone or with substrate modification including vein of Marshal ethanolisation in addition to SVC isolation alone

Official Title
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Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: SVC only
* Procedure: SVC isolation with substrate modification and vein of Marshal ethanol infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Patients scheduled for a repeat ablation of PAF after a previous PVI Confirmation of lasting pulmonary vein isolation at the time of randomization Exclusion Criteria: Patients with persistent atrial fibrillation Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion Left atrial thrombus. Left atrial appendage thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI. Left ventricular ejection fraction <35%. Cardiac surgery within the previous 90 days. Expecting cardiac transplantation or other cardiac surgery within 180 days. Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days. Documented history of a thromboembolic event within the previous 90 days. Diagnosed atrial myxoma. Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment Women who are pregnant or who plan to become pregnant during the study. Acute illness or active infection at time of index procedure Advanced renal insufficiency Unstable angina. History of blood clotting or bleeding abnormalities. Contraindication to anticoagulation. Life expectancy less than 1 year. Presence of a condition that precludes vascular access. International Normalized Ratio greater than 3.5 within 24 hours of procedure - for patients taking warfarin. Patient cannot be removed from antiarrhythmic drugs for reasons other than AF. Unwilling or unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SVC only<br>Patients in Group 1 will receive an SVC isolation only | Procedure: SVC only<br>* Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone<br>|
| Active Comparator: SVC isolation with substrate modification and VoM inf<br>Patients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion | Procedure: SVC isolation with substrate modification and vein of Marshal ethanol infusion<br>* Patients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial tachyarrhythmia 1 year after the index ablation | Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups | 1 year | 
| Safety (complications) | Comparison of the number of procedural complications between groups | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedural time | Comparison of the procedural time between groups | During procedure | 
| Fluoroscopy time | Comparison of the fluoroscopy time between groups | During procedure | 
| RF ablation time | Comparison of the radiofrequency time between groups | During procedure |