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

NCT ID: NCT05427435

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2027-05-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Marshall ethanolisation with specific catheter

Patients will undergo the destruction of Marshall bundles by ethanol infusion with the specific catheter

Group Type: EXPERIMENTAL

Marshall ethanolisation

Intervention Type: DEVICE

Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)

Interventions

Marshall ethanolisation

Destruction of Marshall bundles by ethanol 96% infusion (3 separate injections of 3.3ml)

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas MD DERVAL

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

CHU de Bordeaux

Pessac, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas MD DERVAL

Role: CONTACT

nicolas.derval@chu-bordeaux.fr

(0)5 57 65 64 71 ext. +33

Lorena SANCHEZ BLANCO

Role: CONTACT

lorena.sanchez-blanco@chu-bordeaux.fr

(0)5 57 62 30 91 ext. +33

Facility Contacts

Nicolas Derval

Role: primary

nicolas.derval@chu-bordeaux.fr

Other Identifiers

CHUBX 2021/18

Identifier Type: -

Identifier Source: org_study_id