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

University Hospital of Bordeaux

Status

Enrolling

Conditions

Atrial Fibrillation

Treatments

Device: Marshall ethanolisation

Study type

Interventional

Funder types

Other

Identifiers

NCT05427435

CHUBX 2021/18

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)