Using a special catheter to treat persistent atrial fibrillation by targeting the vein of Marshall

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility of using a specific catheter, the Targeted Endovascular Delivery (TED) catheter, to visualize and ethanolize the vein of Marshall in patients with persistent atrial fibrillation (PsAF). The aim is to systematically include this highly arrhythmogenic structure in the ablation procedure, which may improve outcomes compared to traditional pulmonary vein isolation alone. The study will enroll suitable candidates who have a history of symptomatic PsAF and are undergoing catheter ablation. Participants will be monitored for the effectiveness of this novel approach.

Why it matters

Who can join: the full rules

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)

Where it's running

• CHU de Bordeaux
  Pessac, France Recruiting

Study contacts

• Principal investigator: Nicolas MD DERVAL — Study Principal Investigator
• Study coordinator: Nicolas MD DERVAL
• Email: nicolas.derval@chu-bordeaux.fr
• Phone: (0)5 57 65 64 71

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.