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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jun 16, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach for treating patients with persistent atrial fibrillation (AF), a heart rhythm disorder. The study is testing a special catheter called the Targeted Endovascular Delivery (TED) catheter, which is designed to visualize and deliver ethanol (a type of alcohol) to a specific area in the heart known as the vein of Marshall. The goal is to see if this method can improve the effectiveness of ablation therapy, which is a common treatment for AF that aims to restore a normal heart rhythm.

To participate in this trial, candidates must be adults over 18 years old who have experienced symptoms of persistent atrial fibrillation. They should also be suitable for catheter ablation and have not previously received ethanol treatment in the vein of Marshall. Participants will need to provide informed consent and meet other health criteria to ensure their safety. Throughout the study, participants can expect close monitoring and support from the research team as they undergo the procedure. This trial is currently recruiting participants, and it could provide valuable insights into improving treatments for atrial fibrillation.

Gender

ALL

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 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)