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Recruiting NCT05427435

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

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Trial Parameters

Condition Atrial Fibrillation
Sponsor University Hospital, Bordeaux
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-05-09
Completion 2027-05-16
Interventions
Marshall ethanolisation

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Brief Summary

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.

Eligibility Criteria

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 cutaneou

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