Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol.

Official Title
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The MARSHALINE Study: Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: ALINE + VoM infusion
* Procedure: ALINE only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18 and 85 years Diagnosed with symptomatic AF without previous mitral isthmus line ablation Exclusion Criteria: Previous MI line ablation Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI. LA diameter greater than 55 mm on long axis parasternal view, or left atrial volume more than 200 cc. Left ventricular ejection fraction <35%. Cardiac surgery within the previous 90 days. Expecting cardiac transplantation or other cardiac surgery within 180 days. Coronary PTCA/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 Renal insufficiency Unstable angina. History of blood clotting or bleeding abnormalities. Contraindication to anticoagulation. Life expectancy less than 1 year. Uncontrolled heart failure. Presence of a condition that precludes vascular access. INR 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: ALINE only group<br>Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria | Procedure: ALINE only<br>* In patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria.<br>|
| Active Comparator: VoM group<br>Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria and vein of Marshall (VoM) ethanol infusion | Procedure: ALINE + VoM infusion<br>* In patients assigned to the ALINE + VoM infusion group, extended ablation will be performed according to the ALINE criteria. Additionally, the vein of Marshall will be infused with ethanol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural succes rate | Mitral isthmus block rate after one pass of the mitral line | At time of ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedure time |  | At time of ablation | 
| Fluoroscopy time |  | At time of ablation | 
| Total RF ablation time |  | At time of ablation | 
| Total extent of ablated LA tissue |  | At time of ablation | 
| Cardiovascular-related hospitalizations |  | From time of ablation to one month post procedure | 
| Changes in quality of life (SF36) |  | From inclusion to one month post procedure | 
| Incidence of atrial flutter |  | From time of ablation to one month post procedure |