Status:
RECRUITING
Feasibility of Ethanolization of Vein of Marshall With Specific Catheter in Atrial Fibrillation Ablation
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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. Substr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05427435
Start Date
May 9 2022
End Date
May 30 2027
Last Update
June 17 2025
Active Locations (1)
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1
CHU de Bordeaux
Pessac, France