Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation

Study Overview
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Brief Summary
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In patients with persistent AF (PsAF), ablation limited to pulmonary vein (PV) isolation is the most straightforward approach, but results only in 50% of arrhythmia freedom at 1 year follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been systematically targeted so far, probably because of the absence of dedicated tools to make its ablation simple and easy. We sought to investigate the use of a specific catheter for visualization and ethanolization of vein of Marshall allowing to systematically include this target in the ablation set. The main objective of this study is to demonstrate the feasibility to use the Targeted Endovascular Delivery (TED) catheter specifically for visualization and ethanolization of vein of Marshall.

Official Title
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Prospective Single-centre Study to Evaluate the Feasibility of Ethanolization of Vein of Marshall With a Specific Catheter in the Ablation of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Marshall ethanolisation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suitable candidate for catheter ablation of atrial fibrillation defined as: history of symptomatic persistent atrial fibrillation Redo procedure for persistent AF or paroxysmal AF with isolated PV and no history of ethanol infusion in the VOM. Age > 18 years of both genders Patient affiliated or beneficiary of social security scheme Free, informed and written consent signed by the participant and the principal investigator (at least at the inclusion date and before all exams required for the clinical research) Effective contraception for women of childbearing potential Exclusion Criteria: Minor Documented left atrial thrombus or another abnormality which precludes catheter introduction Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC] Contraindication to iodinated contrast product XENETIX® (iobitridol hypersensivity or at one of these excipients, history of major immediate reaction or cutaneous reaction to XENETIX® infusion, thyrotoxicosis) Hypersensitivity to ethanol Unstable angina or ongoing myocardial ischemia Myocardial infarction within 3 months prior to inclusion Congenital heart disease, where the underlying abnormality increases the ablation risk Severe bleeding, clotting or thrombotic disorder Pregnant, parturient or nursing women Unable or unwilling to provide written informed consent Patient detained by judicial or administrative order Patient under psychiatric care Patient admitted in a social or healthcare establishment for any purpose other than the research Subject to a legal protection order (guardianship, patient under legal protection)

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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: prospective single arm monocentric evaluation study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Marshall ethanolisation with specific catheter<br>Patients will undergo the destruction of Marshall bundles by ethanol infusion with the specific catheter | Device: Marshall ethanolisation<br>* Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute success rate of the procedure | Success rate complete realization of ethanolization procedure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of ethanolization procedure | Time between the entry and the removal of the catheter | 12 months | 
| Time to visualization of Vein of Marshall | Time between 1st injection of iodine (contrast media) and time of visualization of Vein of Marshall | 12 months | 
| Duration of balloon positioning | Time from the 1st injection of iodine to the 1st injection of ethanol | 12 months | 
| Total X Ray duration and radiation dose | Time of exposure to X Ray and total of received radiation dose | 12 months | 
| Incidence of Vein of Marshall dissection | Rate of Vein of Marshall dissection | 12 months | 
| Incidence of periprocedural complications related to ethanolization | Number and rate of adverse events related to ethanolization | 12 months | 
| Incidence of complications related to catheter | Number and rate of adverse events related to the catheter or its procedure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter ablation, Persistent atrial fibrillation, Pulmonary vein isolation, Ethanolization, Ligament of Marshall, Vein of Marshall